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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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