Statement of

Jack E. Henningfield, Ph.D.

Associate Professor of Behavioral Biology

Department of Psychiatry and Behavioral Science

The Johns Hopkins University School of Medicine

and

Vice President, Research and Health Policy

Pinney Associates

and

Innovators Combating Substance Abuse

Robert Wood Johnson Foundation Award

Before the

Interagency Committee on Smoking and Health’s Subcommittee on Tobacco Cessation

October 24, 2002

Thank you for the opportunity to testify on tobacco use cessation.  There are surely few other areas of governmental action with such potential to reduce disease and prevent premature death in our nation.  Great good can be done as we have seen in individual states in which efforts have been made to increase support for smoking cessation while simultaneously increasing access to treatment.  For example, California has witnessed a substantial decline in smoking rates in youth and adults and is the first state in our history to document an actual decline in tobacco-caused lung cancer and heart disease.  Massachusetts appears on a similar course.  The successes of both of these states stand in contrast to trends in their neighboring states which have not made such commitments and have not seen such reversals in smoking.  I have six core points that I would like to make and support:

1.      Most cigarette smokers meet objective medical criteria for nicotine dependence.

2.      We have treatments at our disposal that have met the highest scientific tests for effectiveness.

3.      Improved treatment access leads to increased treatment utilization and increased smoking cessation.

4.      It is important to include treatment as a part of comprehensive approaches to reducing tobacco-caused disease.

5.      Continued research is needed to ensure continued improvement in our ability to treat tobacco dependence and to meet the new challenges that tomorrow will surely bring.

6.      Regulatory flexibility and increased prominence for tobacco treatment throughout the health care system is needed to accelerate treatment development and impact.

Basis for Testimony

I am speaking on my own behalf and not as a representative of the organizations, of which I am a member, consult for, or serve.  I was trained in behavioral science, pharmacology, and other disciplines relevant to understanding drug addiction and have focused on tobacco-related issues for over twenty years.  I have conducted research on tobacco, nicotine and other drugs since 1978 at The Johns Hopkins School of Medicine.  From 1980 until my retirement in 1996, I directed tobacco and other drug research at the Intramural Research Program of the National Institute on Drug Abuse (NIDA).  While at NIDA, I was the primary liaison to the FDA on tobacco products and tobacco addiction treatment.  I contributed to numerous Surgeon General’s reports on tobacco, as well as reports by other agencies in the U.S. and other countries.  I presently serve on the World Health Organization Scientific Advisory Committee on Tobacco Product Regulation, and I am a recipient of a Robert Wood Johnson Foundation Innovators Award, though I am not here as a representative of the Foundation.

Addiction or Dependence

Tobacco addiction is the common term for what is more technically referred to as the medical disorders of nicotine dependence and withdrawal by the American Psychiatric Association.  The World Health Organization uses the terms “tobacco dependence” and “tobacco withdrawal” in its disease classification system.  Dependence and withdrawal result from daily tobacco exposure and are no more voluntary than is the heart disease that may also occur as a function of daily tobacco exposure.  No one smokes a cigarette and decides that he or she will smoke a few hundred thousand more until they can no longer breathe.  In fact, most tobacco users began to use tobacco during adolescence and do not believe that they will still be smoking five years later, but by age 18 two thirds regretted starting and one half have tried to quit.

Tobacco addiction is a powerful, physically based obstacle to achieving the smoke free status that the vast majority of smokers seek to attain.  The scientific basis has now been well documented although new research continues to provide information that should lead to ever more effective ways to prevent and treat addiction.  Repeated daily exposure to tobacco delivered nicotine changes the brain even as smoke toxins induce changes in lung and heart function.  Tobacco users develop addiction even as their bodies develop other diseases.  Thus, despite strong desires to quit by more than 70% of smokers only a few percent successfully achieve lasting nonsmoker status each year.  Going without smoking more than a few hours leads to withdrawal symptoms that are quickly relieved by tobacco.  Thus, the addicted smoker wakes up at low levels of nicotine, feels the physically driven cravings, and achieves virtually instant relief as the nicotine-laden smoke is inhaled into the lungs.  Of course, some smokers, over time, achieve lasting cessation but for most, it is not before serious physical damage is already done.  If they could have escaped their addiction earlier their risk of debilitating disease would have been reduced. 

Treatment

Tobacco users have addictions just as they can have heart disease and lung cancer.  These diseases are debilitating, and are costly to individuals and the United States, and sap precious health care resources.  The irony, and public health tragedy, is that treatment of the addiction can reduce the need for treatment for tobacco-caused diseases.  A variety of behavioral and pharmacological treatments are available that can save lives.  Of course, success depends, in part, on motivation and compliance with treatment regimens but quitting smoking is not a simple matter of "will powering" away the nicotine dependency and ignoring withdrawal symptoms.  Treatment helps the person to manage the physical aspects of the dependence and withdrawal while learning to function without tobacco.  In fact, treatments for tobacco addiction are more effective and tolerable than are treatments for many of the diseases which result as side effects of addiction.

The U.S. Public Health Service has issued Clinical Practice Guidelines describing effective treatments for tobacco dependence.  Similar conclusions and recommendations have been adopted by the U.S. Surgeon General, the World Health Organization, and many other countries and professional organizations.  Smoking cessation treatment is based on science.  Treatment approaches have emerged from research by NIH institutes, pharmaceutical companies and individual investigators and have passed the most rigorous of scientific standards.  These treatments include the various forms of nicotine replacement therapies, Zyban, and other drugs, which are effective even though not specifically marketed for treating tobacco dependence.  They also include behavioral approaches, including problem solving, skills training and social support both during and after treatment. These treatments are life-saving and can contribute to improved health and reduction in serious diseases by enabling smoking cessation.

Access

In 1995, former Surgeon General Dr. C. Everett Koop testified to the FDA in support of making nicotine gum available by over the counter sales to make it more accessible to cigarette smokers.  He said: “with tobacco addiction the treatment is much harder to get than is the cause…Smokers do want help.  And everything that we can do to safely and prudently get them that help will speed the day when we truly have a smoke-free society.”

He made this plea because he understood that treatment is irrelevant if it is not readily accessible.  We can now come to well documented conclusions that making treatment more readily accessible increases treatment utilization.  When nicotine gum and nicotine patch were made available over the counter use increased several fold across our nation.  When health care plans make treatment available, people use it.

Evidence has shown that offering treatments directly to consumers can significantly increase their use of the products.  By collaborating with the appropriate public health agencies and private companies, financial barriers to access to treatment can be reduced.  Distribution of no cost or low cost treatment can and should be selectively distributed to those smokers unable to afford treatment. 

One goal should be that each opportunity to use tobacco should present an equal opportunity to get help.  This could be through toll free telephone numbers and websites on each tobacco product package with a viable means of financial coverage of the treatments.  Funds that could have been earmarked for such use have by and large not been.  It is most disappointing to see so little of the funds from the Master Tobacco Settlement of 1998, which was won on the backs of addicted smokers, being used to help addicted smokers.  I urge the subcommittee to require coverage for effective tobacco dependence treatment in all health care programs and assure that evidence-based tobacco-use treatments have been integrated into the regular health care delivery systems (i.e., medical care, dental care, mental health care, and substance abuse care) for all patients.

Comprehensive Tobacco Control

Treatment utilization and effectiveness can be increased when treatment is a part of comprehensive tobacco control strategies.  Tobacco control components including increased tobacco taxes, reduced opportunities to smoke by workplace and public place smoking restrictions, education to children and adults about the dangers of tobacco and benefits of abstinence, all drive increased interest in cessation and are all important to supporting abstinence.  An historic step in this direction was 1996 with FDA’s issuance of its Tobacco Rule and approval of over the counter marketing of nicotine gum and patch.  FDA understood and worked to address Dr. Koop’s challenge to make it harder to get tobacco and easier to get treatment. 

States such as California, Massachusetts, and Mississippi have demonstrated that youth prevention and adult cessation go best when hand in hand.  Reduced tobacco uptake by young people has been matched by increased cessation in adults.  Studies have shown that when young people can motivate their parents to quit and in turn, that when parents quit smoking their children are half as likely to start and twice as likely to quit if they already had begun to smoke.  In California most cigarette smoking parents now smoke their cigarettes outside of their houses protecting not only their children from environmental smoke but also demonstrating the seriousness of the addiction and its consequences.

Research

Research by NIH and other institutions has been a major driver for treatment development and for improvement of how to use treatment.  It was research on nicotine addiction and the importance of nicotine dosing that led to the development of nicotine gum by a pharmaceutical company.  The nicotine patch was invented by NIH-supported researchers, and the concept that an antidepressant drug could enable smoking cessation was first demonstrated in NIH-supported studies.  Furthermore, research supported by NIH and other institutions has contributed to improved methods for using medications.  This is not to detract from pharmaceutical industry research on new products, but clearly, this is an area of health in which there is a substantial benefit of government-supported research in fostering treatment innovation.

I therefore urge that strong support be given to research that furthers our understanding of the addictive process, treatment innovation, and the coordination of treatment access along with other elements of tobacco control.  The importance of this is strengthened by the emergence of new tobacco industry products and marketing approaches which may be creating new challenges for treatment.  For example, dual use of snuff and cigarettes is being advertised to help smokers manage nonsmoking situations.  If this is adopted to the degree anticipated by the smokeless tobacco companies, we will be faced with adapting treatment strategies to persons addicted to multiple tobacco products and with reduced pressures to quit.  Other products and marketing approaches appear on the horizon and will need to be studied and addressed to enable continued public health improvement.

Regulatory flexibility

Just two decades ago, the HIV AIDS public health bombshell landed in America.  We felt afraid and helpless with a thin science base, and treatment seeming an impossible challenge.  With prioritization given to research, to regulatory flexibility to speed the development and utilization of treatment, and with the coordination of HIV control measures with treatment access, the view of HIV as a death sentence with uncertain transmission has been replaced with the view of HIV as a preventable and manageable disease.  We still have much to do implement our best practices but we have tools undreamed of just 20 years ago.  This achievement is easily the biomedical equivalent of putting a “man on the moon.”  It was enabled by the regulatory flexibility such as the development of fast track approval mechanisms by FDA which accelerated treatment development without lowering standards for safety or eventual assessment of benefits.  Ironically, although these mechanisms have been extended to treatments for the consequences of tobacco dependence such as cancer, these mechanisms have yet to be extended to treatments for tobacco dependence.

We need to encourage FDA to use its authorities to foster treatment innovation not stifle innovation.  We also need to contribute to the development of a regulatory framework for tobacco that reduces the remarkably unfettered capacity of the tobacco industry to make ever more addictive products with ever more insidious marketing approaches.  We need to make it ever more tough to get the disease and easy to get the treatment.  I believe that prioritization of innovation in treatment has enormous potential to improve the health of Americans, to reduce disease and suffering, and to set a standard that the world can learn from and strive to achieve.  I will be most pleased to assist in any way that I can to advance these goals.  I am attaching a paper summarizing treatment recommendations, one summarizing regulatory challenges, one from a conference on tobacco treatment in managed care organizations that describes the challenges and options in greater detail, and an editorial by former Surgeon General C. Everett Koop which summarizes the challenge to our nation

Attached papers:

Ad Hoc Working Group on Treatment of Tobacco Dependence (J.M.Pinney, J.S.Ahluwalia, E.B.Arkin, S.Curry, M.Fiore, J.Gitchell, T.Glynn, J.C.Grumman, D.Hatuskami, J.E.Henningfield, J.Hollis, J.R.Hughes, C.O.Maule, R.Neff, J.Ockene, C.T.Orleans, S.Shiffman, J.Slade)  Realignment of the nation’s tobacco agenda: The need to treat tobacco dependence.  Preventive Medicine, 32: 95-100, 2001

Henningfield, J.E., and Slade, J.  Tobacco-dependence medications: Public health and regulatory issues.  Food and Drug Law Journal, 53, supplement: 75-114, July, 1998.

Henningfield, J.E.  Tobacco dependence treatment: scientific challenges; public health opportunities.  Tobacco Control, 9(Supplement I): i3-i10, 2000.

Koop, C.E.  Don’t forget the smokers.  Washington Post.  Sunday, March 8, 1998, C07 

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