Interview #1:

'Diverse Treatment, Policy Approaches Are Needed'

C. Tracy Orleans, Ph.D., senior scientist at the Robert Wood Johnson Foundation, is responsible for research-based programs in health and behavior, tobacco control and chronic disease management, as well as for initiatives that translate behavioral science research into programs and policies that benefit the public. Much of her work has focused on developing and evaluating model tobacco control and treatment programs for community and health care settings. A clinical psychologist, she is an adjunct member of the behavioral science program at the Fox Chase Cancer Center in Philadelphia and adjunct professor in the Department of Psychiatry at the University of Medicine and Dentistry of New Jersey.

Q: What role do tobacco-use cessation initiatives play in the nation’s overall tobacco control strategy?

A: With more than 400,000 deaths annually and 3,000 children and teens becoming new smokers each day (17), tobacco-use prevention must remain the nation’s top priority. However, efforts to reduce current smoking prevalence – which has stabilized at about 25 percent for adults and is slightly higher for teens and young adults (5) – will produce more immediate reductions in tobacco-caused death and disease, reductions that will occur over the next 10 to 30 years. Therefore, we must aggressively pursue both prevention and cessation.

Q: How has the nation’s approach to tobacco-use cessation evolved during the past two decades?

A: The development of effective drug therapies, including bupropion and a variety of prescription and over-the-counter nicotine replacement products, combined with the movement toward low-cost self-help and brief primary care treatments, represent major treatment advances. These treatment strategies benefit individual smokers, but we also have seen a shift toward strategies at the worksite, in health plans and in the community, all aimed at entire populations.(11) Furthermore, over the years we have gained an awareness of the power of prevention, macro-policy and environmental interventions to motivate and support population-wide cessation.(11) The evolution toward preventative approaches began in the 1980s with the emergence of new research documenting the powerful impact on tobacco consumption of increasing prices, limiting youth access and imposing clean indoor air laws. At the same time, we saw the advent of comprehensive statewide tobacco control programs such as California’s vanguard Proposition 99 program and the similar ASSIST, SmokeLess States and Impact programs.

Q: Has this evolution made a difference?

A: Many more smokers have access to effective treatments today than in the past. National rates of provider advice to quit have risen significantly during the past 25 years. Data from the 1996 California Tobacco Survey show that 21 percent of smokers who tried to quit in the previous year used an effective cessation method, such as counseling, nicotine patch or gum or Zyban.(11) This is a higher rate than the 10 percent to 15 percent reported by the 1986 national Adult Use of Tobacco Survey.

Q: Do prevention-oriented macro-level interventions have a greater impact on individual treatment?

A: According to the National Cancer Institute, if comprehensive tobacco control programs like California’s were implemented nationally, quit rates would increase by one-third, creating 500,000 new ex-smokers each year.(11) A 20 percent increase in the cost of cigarettes would result in 222,000 new quitters per year. In addition, more than 750,000 additional successful quits are projected if the health care system could assure that 90 percent of smokers received advice from their health care providers to quit and 50 percent of those planning to quit went on to receive brief counseling.

Q: How are the recent U.S. Public Health Service clinical guidelines affecting the general approach to tobacco-dependence treatment?

A: The original Agency for Health Care Policy and Research guideline (17), issued in 1996, and the updated year 2000 U.S. Public Health Service guideline (8) have spurred wide efforts to educate the nation’s health care providers about brief interventions. The Year 2000 guideline advocates a "five-A" approach: ask patients about smoking, advise smokers to quit, assess willingness to make a quit attempt, assist those who want to quit and arrange follow-up visits with those trying to quit.(8) The clinical guidelines also have provided a platform for important policy advances. For instance, based on the 1996 guideline, the National Committee for Quality Assurance now includes provider advice to quit as a measure of health plan quality, and a large number of the nation’s managed care plans are now using the guidelines to design their tobacco-dependence treatment benefits. Likewise, the guidelines are providing impetus to add Medicare coverage and to expand Medicaid coverage of tobacco-dependence treatment. In addition, the new guideline’s strong recommendation for telephone-based approaches has fueled new efforts to develop state, regional and health plan telephone quit lines for smokers.

Q: Has insurance coverage of treatment for tobacco use increased in recent years?

A: Yes, but not enough. The 1996 and 2000 tobacco-dependence treatment guidelines recommend including effective counseling and drug therapy as covered services for all subscribers, but we are far from achieving that goal. For example, some Medicaid agencies do not cover any tobacco-dependence treatment, and fewer than half offer any coverage for counseling – despite the fact that counseling is the treatment of choice for the nation’s pregnant smokers, most of whom receive prenatal care through Medicaid. On the other hand, a survey of health care plans in the year 2000 showed an increase since 1997 in full coverage of six out of eight treatment services, including drug therapy and counseling.

Q: Do we need to place more emphasis on smoking cessation within specific populations?

A: Much more work is needed to improve the reach and efficacy of programs for chronically underserved low-income and minority populations, including African Americans and Native Americans, for whom tobacco-use rates are highest and access to proven treatments is lowest. Efforts to reach pregnant smokers also are very important because this group is uniquely motivated to quit and because of growing evidence of nicotine’s neurological effect on the fetus. In addition, we need to focus on older smokers, who make fewer quit attempts, often fearing it may be too late to quit but who appear to be more likely to succeed when they get appropriate help. Finally, efforts are under way to accelerate the development of effective cessation interventions for adolescent and young adult quitters to prevent a lifetime of addiction.

Interview #2:

'New Drug, Behavioral Approaches Help Smokers Quit'

Saul Shiffman, Ph.D., is a clinical psychologist who has conducted clinical research on smoking, nicotine addiction, smoking cessation and relapse for the past 28 years. He is professor of clinical psychology and health psychology at University of Pittsburgh. Through Pinney Associates in Pittsburgh, Dr. Shiffman also provides consulting services to pharmaceutical companies about the development of smoking cessation methods.

Q: What strategies are most effective in helping adults quit smoking?

A: The ideal strategy combines pharmacological treatment and behavioral treatment. Pharmacological treatment uses nicotine replacement therapy or non-nicotine medications. Behavioral strategies include face-to-face treatment, telephone counseling and advice tailored for the individual.

Q: What is nicotine replacement therapy, and how does it work?

A: Nicotine replacement is the broadest class and most proven drug therapy for tobacco-use treatment. When a person stops smoking, the brain – which has been used to getting constant spiked doses of nicotine from smoking – needs some time to adjust to being without nicotine. The sudden shift to being without nicotine causes withdrawal symptoms – irritability, restlessness, difficulty concentrating and craving. Nicotine replacement therapy provides temporary, low, slower doses of nicotine in order to blunt withdrawal and help people concentrate on quitting. The nicotine, which does not contain the toxins found in smoke, can be administered in a number of forms. Over-the-counter products include the patch, which administers nicotine slowly through the skin, and chewing gum, which administers it through the skin in the mouth. Another product, the prescription inhaler, looks like a cigarette holder; the person puffs on it, and nicotine is absorbed through the mouth. Prescription nasal spray deposits nicotine in the nasal passages. The prescription drug bupropion, which has the trade name Zyban, has been on the market for some time as an antidepressant and has been shown to help with smoking cessation.

Q: What kinds of counseling or other behavioral strategies work well?

A: The trend is to combine multiple methods that have been shown to work well. Effective methods include problem-solving treatments, which teach people to anticipate difficulties and to cope with the temptation to smoke, and provision of support from a group or from family members, co-workers or friends. Aversive therapy, which is less used today but remains effective, involves smoking so much that it makes the person feel sick, thereby establishing a negative association. It is equally important to talk about what does not work. For example, acupuncture and hypnosis have not been shown to be effective. Relaxation and exercise are helpful as part of a package but are not effective on their own.

Q: Are self-help materials like pamphlets effective?

A: Self-help materials are helpful for information purposes, but by and large have not shown a clinical effect in cessation trials. The bright spot is tailored treatment. This involves gathering information about a person and then producing a customized pamphlet, usually using a computer, that addresses that person’s needs.(16)

Q: Is telephone counseling a useful tool?

A: Telephone counseling is effective, especially when it involves outreach from a counselor. Having people call in to a quit line also has been demonstrated to be effective, but smokers tend not to use the service. Telephone counseling generally has been provided through organized smoking cessation programs. Some of the more innovative managed care organizations have developed programs in which trained counselors make outbound calls.

Q: Can interactive technology, such as the Internet, help smokers quit?

A: Clearly, computers enable new forms of interactivity, although to my knowledge Internet applications have not yet been tested in smoking cessation clinical trials. The Internet provides an ideal medium for tailored materials, and it can be used to send periodic e-mail reminders or to make users aware of new material. In the future, we also will see more programs contained on CD-ROM. However, it is important to remember that technology itself is not going to help anybody quit. Rather, good, solid behavioral intervention and behavior change principles can be given a boost by appropriate technology.

Q: What new drug therapies are on the horizon?

A: A lot of pharmaceutical companies are testing drugs originally created for weight control or depression. Companies also are testing novel strategies, such as a vaccine that would sensitize the body’s immune system to nicotine. Currently, if people slip and have a cigarette, they can relapse completely, in part because of the central nervous system jolt they get out of that cigarette. With the vaccine, when nicotine appears in the bloodstream, immune factors would attach to it and keep it from getting into the brain. Another interesting but unproven technology would block some of the enzymes that clear nicotine from the bloodstream. With this technology, a bit of nicotine taken by smoking or nicotine replacement would last a long time because the body would not metabolize it so fast. Therefore, the person would be less motivated to smoke more or smoke again. Companies also are looking at ways to make nicotine replacement products easier to use or more palatable; even modest improvements could increase its effectiveness.

Q: What developments do you see on the behavioral intervention front?

A: Unfortunately, there has been less innovation in behavioral treatment than in pharmacological treatment. The field has been more concerned with packaging and disseminating what we already think works – getting it to more people, making it more attractive, putting it on the Internet, making it more tailored. Those are all good improvements, but we are not seeing a lot of new or creative thinking in behavioral treatment. One strategy that should receive more attention than it has helps people approach quitting gradually in a very structured way. Rather than letting them decide how much to reduce smoking on their own, it gives smokers clear, structured guidelines. This is a promising avenue.

Q: How can health care providers help their patients quit smoking?

A: Health care providers have an essential role for two reasons. First, they have extraordinary access to smokers. It has been estimated that health care providers see 70 percent of smokers each year, so the opportunities are great.(18) Second, providers are in a unique position to deliver a very powerful and personal message. Smokers know that smoking is bad for people, but health care providers can say, "Here’s why it’s bad for you, John." In the past, we have made the mistake of trying to get physicians to provide the treatment or counseling. Expecting them to do so has become even more difficult in this era when physicians have too little time. The best role for physicians is to motivate patients to move toward a quit attempt and then direct them toward effective treatment, but not implement the treatment themselves. On the behavioral side, they can recommend formal treatments or encourage the use of tools such as telephone counseling lines or tailored materials. Physicians also can prescribe medications or recommend over-the-counter treatments.

Q: What should be the individual smoker’s role?

A: Quitting smoking is one of the most difficult, but most important, changes people can make. Too often, though, quit attempts are undertaken too casually. People often fail not because nothing has worked for them, but because they stop doing what works for them. Making a plan, setting a specific quit date and then sticking with it are important to success.

Do Tobacco Control Programs Save Lives?

Comprehensive tobacco control programs – those that combine educational, clinical, regulatory, economic and social approaches – may be effective in reducing cigarette consumption and smoking prevalence (18), but do they actually save lives?

In California, home to the nation’s oldest and most comprehensive voter-initiated tobacco control program, the answer is a resounding yes, asserts Stanton Glantz, Ph.D., professor of medicine and a researcher in the Institute for Health Policy Studies at the University of California, San Francisco. Glantz and co-investigator Caroline Fichtenberg, MS, studied the rate of heart disease deaths following implementation of California’s program.

When implemented in 1989 with revenue allocated from state cigarette taxes, the California Tobacco Control Program combined a cigarette tax increase, an aggressive media campaign and community-based programs to promote clean indoor air and encourage a smoke-free society. Past research has associated the program with declines in the state’s per capita cigarette consumption, smoking prevalence and rate of increase in youth smoking.(18)

In their study, Fichtenberg and Glantz hypothesized that the program also has reduced heart disease death rates.

"Whereas the excess risk of death from cancer or lung disease associated with smoking changes slowly after people stop smoking, the excess risk of heart disease declines rapidly," they write in The New England Journal of Medicine.(7) "Because of this rapid reduction in risk, one would expect to begin to see changes in the rate of mortality from heart disease within a year after changes in cigarette use."

Examining state and national mortality data, Fichtenberg and Glantz found that between 1989 and 1992, the death rate from heart disease decreased significantly more in California than in the rest of the United States and that changes in heart disease mortality — prevention of 59,900 deaths — mirrored reductions in per capita cigarette consumption.(7)

Notably, the researchers found that when program support was cut back beginning in 1992, the rate of decline in heart disease deaths also diminished. They project that the reduction in program funding and effectiveness was associated with 15,000 more deaths and the sale of 1 billion more packs of cigarettes from 1993 through 1997 than would have been expected had the program support been maintained.(7)

"This is the first time anybody has shown a connection between a tobacco control program and death rates," Glantz said in an interview.

"If you run an effective tobacco control program, you can rapidly reduce cigarette consumption and heart disease deaths, and you don’t have to wait a long time to see benefits. It happens almost immediately, which is something people didn’t previously appreciate," he asserts. "Conversely, when you cut back or water down a program, that is also reflected in tobacco consumption and deaths."

Even for Older Adults, It’s Not Too Late to Quit

Research tells us that quitting smoking at any age, including after age 65, can improve a person’s health and extend his or her life. Even after 30 or more years of regular smoking, quitting offers significant benefits.(10) For example, a person who smokes more than 20 cigarettes a day and quits at age 65 will increase his or her life expectancy by two to three years.(13)

Despite the known benefits of quitting, approximately 13 percent of people 65 and older smoked in 1995,(3) and in 1990, 287,000 people aged 65 and older died from smoking-related causes – accounting for about 70 percent of all smoking-related deaths in this country.(2)

"The new science of healthy aging is teaching us that there are very real benefits when you quit smoking at any age, even over the age of 65," says Catherine Gordon, RN, MBA, director of health promotion and disease prevention at the Health Care Financing Administration (HCFA). "When people stop smoking, we see almost immediate improvements in circulation and lung function, improvements in functional status, reductions in cardiovascular illnesses and mortality and improvements in quality of life over time."

Gordon notes that Medicare currently does not pay for smoking cessation services, although the economic burden of tobacco use to the federal insurance program is quite significant. In 1994, smoking-related illnesses consumed more than 9 percent of the Medicare budget,(19) and between 1995 and 2015, tobacco-related diseases are expected to cost Medicare about $800 billion.(1)

To tackle the issue of smoking within the Medicare population, Gordon’s office will soon launch a path-breaking smoking-cessation demonstration initiative aimed at seniors in Alabama, Florida, Missouri, Nebraska, Ohio, Oklahoma and Wyoming.

The initiative will test three smoking-cessation Medicare benefit options – counseling only, counseling with FDA-approved smoking-cessation drugs and a telephone quit line with nicotine replacement therapy – against the usual care of providing information only. In addition, the project will educate health care providers about how to use the U.S. Public Health Service’s recent clinical guideline on treating tobacco use and dependence.(8)

"Most smokers would like to quit, but they don’t really know how or they lack the confidence to quit," notes Gordon. "This project will help older people get serious about quitting, and it will give providers an incentive to become more involved with smoking cessation."

Treatment Improvement: In the Palm of Your Hand:

Palm-top computers are hailed by users as a nifty tool for storing and sharing personal calendars, telephone books and other data. For more than a decade, though, researchers like clinical psychologist Saul Shiffman, Ph.D., of the University of Pittsburgh also have looked to using this lightweight, portable technology for higher purposes.

Shiffman and others concerned with tobacco-use treatment are harnessing the palm-top’s potential to better understand the experience and process of quitting smoking. This understanding, Shiffman says, is critical to developing new, more effective treatment methods.

Many research studies ask participants to recall experiences retrospectively, but there is an enormous amount of evidence that people’s memories are not always accurate, he says. Palm-tops can provide real-time data gathered in the person’s natural settings – a method shown to render more accurate, less biased results.(14, 15, 16)

In a current University of Pittsburgh study funded by the National Institute on Drug Abuse, approximately 350 smokers in the process of quitting were randomized to receive high-dose nicotine patch treatment or a placebo. Each participant was given a palm-top that signaled him or her at random points throughout the day.

When the palm-top beeped, the user was prompted to answer questions about his or her current mood, craving to smoke, activities, alcohol and coffee use, and intrusive or obsessive thoughts about smoking. Participants also entered data whenever they smoked or felt a strong temptation to smoke. Later, the electronic diary entries were downloaded from the palm-top at the research facility or by modem installed at the study participant’s home. The results are now being analyzed.

"We’re developing a detailed picture of what it’s like to quit smoking and what pathway people travel to get to the point where they go back to smoking or end up succeeding," Shiffman says. "In part, we’re trying to understand which parts of the quitting process are favorably affected by the patch and which parts remain a behavioral challenge to the person. The next step is to turn what we learn into treatment strategies."

Shiffman and colleagues began using very primitive palm-top computers for this purpose back in 1987. As palm-top technology has become more sophisticated, he and others have studied and evolved its use in creating electronic diaries to gather data about smoking cessation, as well as alcohol use, pain, stress and coping and cardiovascular health. Taking their research one step further, Shiffman and other experts recently co-founded a firm, Invivodata, Inc., to market their methods for use in clinical trials.

The Research:

1. Califano JA. (1995). The impact of substance abuse. Tobacco Control, 4(Suppl 2):S19-24.

2. Centers for Disease Control and Prevention. (1993). Physician and other health-care professional counseling of smokers to quit—United States, 1991. Morbidity and Mortality Weekly Report, 42(44):854-857.

3. Centers for Disease Control and Prevention. (1997). Cigarette smoking among adults—United States, 1995. Morbidity and Mortality Weekly Report, 46(51):1217-1220.

4. Centers for Disease Control and Prevention. (1999). Best Practices for Comprehensive Tobacco Control Programs – August 1999. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

5. Centers for Disease Control and Prevention. (2000). Fact Sheet: Cigarette Smoking Among Adults – United States, 1997.

6. Centers for Disease Control and Prevention. (2000). Fact Sheet: Cigarette Smoking-Related Mortality.

7. Fichtenberg CM, Glantz SA. (2000). Association of the California Tobacco Control Program with declines in cigarette consumption and mortality from heart disease. The New England Journal of Medicine, 343(24):1772-1777.

8. Fiore MC, Bailey WC, Cohen SJ, et al. (2000).Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service.

9. McGinnis JM, Foege WH. (1993). Actual causes of death in the United States. JAMA, 270(18):2207-2212.

10. Morgan GD, Noll EL, Orleans CT, Rimer BK, Amfoh K, Bonney G. (1996). Reaching midlife and older smokers: Tailored interventions for routine medical care. Preventive Medicine, 25(3):346-354.

11. National Cancer Institute. (2000). Population Based Smoking Cessation. Washington, DC: U.S. Department of Health and Human Services. NIH Publication No. 00-4892.

12. Orleans CT, Cummings KM. (1999). Population-based tobacco control: Progress and prospects. American Journal of Health Promotion, 14(2):83-91.

13. Sachs DPL. (1986). Cigarette smoking: Health effects and cessation strategies. Clinical Geriatric Medicine, 2(2):337-362.

14. Shiffman S, Hufford M, Hickcox M, Paty Ja, Gnys M, Kassel JD (1997). Remember that? A comparison of real-time vs. retrospective recall of smoking lapses. Journal of Consulting and Clinical Psychology, 65:292-300.

15. Shiffman S, Hufford MR, Paty J. (2001). Subject experience diaries in clinical research, part 1: The patient experience movement. Applied Clinical Trials, February 2001. (10)2:46-56.

16. Shiffman S, Paty JA, Rohay JM, Di Marino ME, Gitchell J. The efficacy of computer-tailored smoking cessation material as a supplement to nicotine polacrilex gum therapy. Archives of Internal Medicine 2000; 160: 1675-1681.

17. Stone AA, Shiffman S. (1994). Ecological momentary assessment in behavioral medicine. Annals of Behavioral Medicine, 16:199-202.

18. U.S. Department of Health and Human Services. (1996). Clinical Practice Guideline Number 18: Smoking Cessation. Agency for Health Care Policy and Research Publication No. 96-0692.

19. U.S. Department of Health and Human Services. (2000). Reducing Tobacco Use: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention, Office on Smoking and Health.

20. Zhang X, Miller L, Max W, Rice DP. (1999). Cost of smoking to the Medicare program, 1993. Health Care Financing Review, 20(4):179-196.

The Center for the Advancement of Health is an independent nonprofit organization that promotes greater recognition of how psychological, social, behavioral, economic and environmental factors influence health and illness. The Center advocates the highest quality research and communicates it to the medical community and the public. The fundamental aim of the Center is to translate into policy and practice the growing body of evidence that can lead to the improvement and maintenance of the health of individuals and the public. The Center was founded by the John D. and Catherine T. MacArthur Foundation and the Nathan Cummings Foundation, which continue to provide core funding. Funding for this series was provided by the Robert Wood Johnson Foundation.

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