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Nicotine Addiction
The Health Effects of Tobacco and 
The Scientific Basis For Regulatory Approaches

Statement by Jack E. Henningfield, Ph.D.  

Before the Committee on Labor and Human Resources
  United States Senate
  February 24, 1998     

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Published On: June29, 2001          Updated On: August 07, 2001
© Terence T. Gorski, 2001

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Thank you for the opportunity to comment on the health effects of tobacco and the scientific basis for various regulatory approaches. I am a scientist by training and experience who has specialized in drugs which act in the brain, including addictive or dependence producing drugs. Throughout my testimony, I will use the terms drug addiction and drug dependence interchangeably as addiction is simply the more widely used term for what is more technically referred to as dependence. 

My experience includes approximately 25 years of study and research concerning addictive drugs although during the past two decades I have focused more on tobacco and nicotine. I was Chief of the Clinical Pharmacology Research Branch of the Intramural Research Program (or the Addiction Research Center) of the National Institute on Drug Abuse (NIDA) from 1989 until my retirement in 1996. From 1980 until 1989 I held various research positions at NIDA including Principle Investigator of a U.S. Army contract to study the psychoactive effects of various drugs, Acting Chief of the Human Performance Assessment Laboratory, and Chief of the Biology of Dependence and Abuse Liability Testing Section. During my tenure at NIDA I assisted in the preparation of several Surgeon General's Reports and was a scientific editor of the 1988 Report entitled Nicotine Addiction. I also advised FDA, on behalf of NIDA on the scientific basis of the consideration of nicotine as a drug and tobacco products as drug delivery systems.  

My prepared comments will address each of the four questions posed to me in the letter from Senator Jeffords which served as my invitation to participate in this hearing. My oral testimony will highlight the main points of the following more detailed written statement. I also submit a document describing major research issues and needs from the Society on Research on Nicotine and Tobacco, a document describing major treatment issues and needs from the Center for the Advancement of Health, and a summary of my earlier comments in a White House briefing last July.  

It may be useful to provide the general scientific basis regarding our understanding of the characterization of nicotine as a drug and tobacco products as drug delivery devices. Because of time constraints, the focus of my comments will be on cigarettes, although in principle, I believe that legislation should provide the means to provide regulatory oversight of the development, manufacture and marketing of all tobacco products. Let me begin with a few background observations on our understanding of the nicotine as a drug and cigarettes as drug delivery devices.  

Nicotene As A Drug - 
Cigarettes As Drug Delivery Devices

Although the tobacco industry would apparently like its consumers to believe that cigarettes are basically rolls of fine tobacco in pristine paper to be smoked for sensory pleasure, the reality is that cigarettes are extraordinarily highly engineered drug delivery devices which employ many techniques to control the amount of nicotine that gets past the sensory receptors of the mouth and into the blood stream. In fact many of these methods are similar to those employed by pharmaceutical manufacturers to control the delivery of their drugs to the bloodstream. Research supported by the U.S. Public Health Service (USPHS) has documented these conclusions and we now have seen the truth of these observations verified by documents from the tobacco industry itself.  

I also believe that the efforts of various research institutions of the USPHS, as well as the Food and Drug Administration (FDA), during the last quarter of the 20th century will stand as one of the major achievements in our nation's ability to advance the health of its citizens. The unfortunate aspect of what the Public Health Service has to accomplish is that the process could have been greatly accelerated had the tobacco industry been more forthcoming with its research and conclusions regarding tobacco and nicotine.  

Since the 1970s USPHS research has brought us far beyond the point that had been summarized in the 1964 Surgeon General's Report (p. 354) whereby cigarette smoking was considered to be a 'habit' that was 'related to psychological and social drives, reinforced and perpetuated by the pharmacological actions of nicotine on the central nervous system.' Our understanding of the process and control of tobacco addiction has increased exponentially since that time with the conduct and publication of thousands of scientific studies on the chemical, physiological, behavioral, epidemiological, and medical underpinnings. Moreover, much of this progress has been in step with major advances in our understanding of the process of drug addiction more generally. As concluded by the Director of the National Institute on Drug Abuse, Dr. Alan Leshner, 

'addiction is, at its core, a consequence of fundamental changes in brain function.' And further 'It is a brain disease for which the social contexts in which it has both developed and is expressed are critically important.' (Science, 278:45-47, 1997) 

The understanding of how drugs affect brain function to reduce the capacity of individuals to control their use of drugs, of the importance of drug delivery systems ranging from the paraphernalia of the crack cocaine user to the cigarette of the tobacco user, and the diversity of physiological, behavioral and social effects and consequences of addiction all must be considered in understanding the addiction process and developing rational regulatory approaches. It is essential to affirm, if not strengthen the FDA's ability to use all of its proven expertise and regulatory authority to enable rational regulation of existing products as well as the flexibility to regulate products and marketing approaches of tomorrow.  

Nicotine Is A Dependence Producing Drug

We now understand that nicotine meets all criteria used by the World Health Organization, the Drug Enforcement Administration, the Food and Drug Administration, and the American Psychiatric Association to define dependence producing or addictive drugs. These organizations rely upon objective scientific evaluations of the effects of substances in animal and human tests, and human clinical studies to determine whether products brought to their attention should be categorized as dependence producing or controlled substances. Nicotine delivered by cigarettes meets all of the criteria of these organizations. We also understand that alternative delivery systems can greatly reduce the toxic and addictive effects of nicotine as demonstrated by medicines such as transdermal nicotine patches.  

Some of the specific advances are relevant to all of the questions which have been posed to me. For example, we have a much more exquisite understanding of the importance of the dose of nicotine that actually reaches the blood steam as a determinant of the effects on the user. This goes to the heart of issues such as the importance of highly nicotine concentrated Y-1 tobacco and the use of ammonia compounds in tobacco product manufacturing, which we now have learned were tobacco industry tools to control and manipulate the nicotine dose, not necessarily to increase the dose of cigarettes per se.  

Low Tar Cigarettes:  We now understand that control of nicotine dose was brought to extremely sophisticated heights, in part to enable what we now recognize as a disingenuous program to develop so-called low tar and nicotine delivering cigarettes. These products were intended to 'delay the quitting process' and to 'reassure smokers, to keep them in the franchise as long as possible' by appearing to provide them with a 'reduction of health hazard' (Excerpts from Imperial Tobacco Limited Internal Documents available from the National Clearinghouse on Tobacco and Health, Canada). A critical element of the so-called low tar and nicotine cigarette approach was to ensure that consumers actually could achieve full doses of nicotine necessary to produce and sustain addiction and provide other pharmacological effects which keep people smoking, such as effect on mood, body weight and mental function. These products constitute a practical demonstration of how the tobacco industry itself took advantage of the cigarette as a device that could be manipulated to suit its market driven ends.  

Nicotine Withdrawal Syndrome:  We now understand that the nicotine withdrawal syndrome is due to the decline of nicotine in the bloodstream and that symptoms of nicotine withdrawal can be reduced by infusions of nicotine into the blood stream. We understand that these withdrawal effects include disruption of brain function which make it difficult if not impossible for many people to function in social and professional situations. Perhaps the most celebrated case of this was that of the New York Mets pitcher, Pete Harnish, on the opening game of Major League Baseball in 1997 when, after a few innings, his performance disintegrated, in part as a consequence of the fact that he was at about the peak of his nicotine withdrawal symptoms due to his termination of smokeless tobacco use a few days earlier. Unfortunately for Mr. Harnish, he was apparently not aware of other major advances of the USPHS supported research which could have enabled him to perform at peak level. For example, he could have obtained treatment for his dependence and withdrawal, such as nicotine medication based therapy. Then he could have quit smokeless tobacco use without the brain dysfunction associated with tobacco withdrawal.  

Biomedical Treatment for Nicotine Dependence:  In fact, the advent of biomedical treatment for nicotine dependence illustrates the importance of the basic research process in understanding the addictive process, as well as the importance of NIH-supported research in its evaluations of medications to complement, and in some cases stimulate pharmaceutical company research. For example, although the first effective medicine for treating tobacco dependence, nicotine gum, was developed by a Swedish pharmaceutical company (A.B. Leo), the means to most effectively use it, as well as the evaluation of the extent and limitations of its beneficial effects was accomplished extensively by NIH-supported research. The first published report of using a transdermal nicotine patch was the product of NIH supported research grant in the early 1980s. This report led several pharmaceutical companies to develop and market their own patches. Although patent attorneys may continue to dispute who intellectually owns which aspects of this invention, there is no serious debate that this major form of medical treatment for one of the most costly and deadly of all medical disorders is heavily indebted to NIH research that was focused on understanding and treating the nicotine addiction process. As important as these and other treatment advances have been, we have much yet to learn if we are to be able to more effectively treat a broader range of tobacco addicted persons. Our situation may not be unlike the discovery of penicillin in the 1920s; this medicine was a tremendous life-saving medical advance but was only the first in what was soon seen to be a need for additional antibiotics to treat the individuals who could not tolerate penicillin or had infections that were resistant to penicillin. Expanding the armamentarium of medicines to treat a still expanding tobacco epidemic across an extremely diverse population of tobacco users requires active research and a rational regulatory process.  

Of course, effective treatments for infectious disease, or tobacco dependence, have little impact on public health if they are not accessible to those in need. Here too we have learned another important lesson that I believe is relevant to today's hearing. Specifically, it concerns the importance of an appropriate regulatory process. 1996 was an historic year in the fight against tobacco-caused disease for two reasons: First, the FDA's Tobacco Rule, finally brought the promise of meaningful regulatory oversight to cigarettes and smokeless tobacco. Second, the FDA's decision to permit the over-the-counter (OTC) marketing of nicotine gum and patch as treatments for tobacco dependence greatly expanded the accessibility of these medications to the public. As reported in the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (Sept. 19, 1997), and subsequently re-reported in the Journal of the American Medical Association (Dec. 17, 1997), the over-the-counter availability of nicotine medications, combined with increased promotion of quitting smoking, dramatically increased the number of cessation efforts accompanying the annual Great American Smokeout. Further, a forthcoming paper in the British Medical Association's Journal, Tobacco Control, estimates that the OTC availability of nicotine gum and patch appeared to have already increased the annual number of people who successfully quit smoking by 20% in the United States. In any area of medicine and public health, such successes would be considered a stunning achievement.  

Of course we have much yet to do to meet the needs of those who are unwilling or unable to quit smoking. We must address the needs of those many special populations of people who need treatment for their addiction, including adolescents, the elderly, and people with other psychiatric and behavioral disorders. We also have much yet to do to foster and enable the level of innovation in developing treatments for tobacco dependence to rival the level of innovation in tobacco products. Finally, we have much yet to do to if we are to make treatments for tobacco dependence as easy to get and as attractive to tobacco users as the tobacco products which are killing them. These challenges are surmountable with a strong research based approach and rational regulation.  

With the foregoing as background to the questions posed to me, let me briefly comment more specifically on each of these questions. I note that my views are generally consistent with those that have been provided to the committee in recent weeks by Dr. John R. Hughes, ENACT, Mr. Matthew L. Myers, and Mr. Scott D. Ballin. Therefore, I will not recapitulate all of their points but rather will highlight what I believe are core issues.    

(1) What is the current state of the science on tobacco use research? What do we know? What do we need to learn?  

Drug addiction research, including research on nicotine and tobacco, has advanced to rival any other area of modern biomedical science and includes the application of sophisticated brain imaging and behavioral research techniques to better understand the effects and mechanisms of action of administration and withdrawal from addictive drugs. We now have many of the technological and intellectual assets to rapidly advance our understanding of the development of the addiction process in young people ,and adults and to develop more effective strategies to prevent and treat tobacco addiction.  

Major unanswered questions include how to address the diversity of treatment needs posed by the diversity of tobacco users. For example, there has been little study of the treatment needs of adolescents, who are in a trajectory of increasing addiction severity; of the elderly who could also benefit by effective treatment; by our increasing ethnically and socially diverse populations of tobacco users; and in people with other illnesses ranging from heart disease to depression to alcoholism.  

From the perspective of prevention, it is clear that every effort needs to be made to reduce the risk of children even trying cigarettes. However, because it is likely that many young people will at least occasionally sample cigarettes, we need much more information on how to reduce the risk of progression from occasional tobacco use to addiction--again our efforts must reflect the ethnic, social and individual diversity among young people.  

Although it is clear that the risk of developing tobacco-caused disease is related to the amount and/or frequency of exposure to tobacco toxins, it is now clear that the approach offered by the so-called low tar cigarettes has been a public health disaster. Reduction of exposure to tobacco toxins using medications and behavioral strategies appears viable. The scientific and public health challenge that can be resolved scientifically, is how to most effectively reduce exposure in those who are not yet ready or able to achieve total cessation without undermining prevention and cessation efforts.

(2) How will the tobacco use research components of the proposal help to promote public health by reducing tobacco consumption, particularly among youth?  

Scientific research can lead to the identification of forces ranging from the genetic to social, which alter the vulnerability, and conversely, the invulnerability, to developing tobacco addiction.  

Scientific research can form the basis for developing and evaluating strategies for preventing and treating tobacco addiction.  

The benefits may be limited, however; if NIH is not directed to give high priority to research on the process, prevention, and treatment of tobacco addiction; if there is not a system of accountability to ensure that funds are not diverted into other areas; and if there is not strong encouragement to ensure adequate research to meet the needs of heretofore understudied populations such as youth, elderly, ethnically and socially diverse populations, and those with other drug and mental disorders.  

Furthermore, it must be recognized that NIH does not traditionally place high priority on research that is viewed as more important from a regulatory perspective than from a science and medicine perspective; yet many of these regulatory issues need to be more fully studied if regulation is to continue to evolve in a rational and public health minded manner. FDA would appear to be the most appropriate agency to determine and fund research that is essential to rational regulation, such as research on the effects of additives as ammonia compounds on nicotine bioavailability; research on the threshold for effects for an addicting nicotine delivering product; and research that could enable more accurate labeling of the delivery of tar, nicotine and other substances to consumers when they use tobacco products. It would therefore appear critical to ensure that FDA be provided with both the mandate and resources to conduct or contract for the conduct of such research.  

In a similar vein, it must be recognized that continuous and comprehensive monitoring of the use of all forms of tobacco is critical to enable appropriate regulation, to detect undesired effects of regulation and therefore quickly adjust regulation. This is the sort of surveillance and epidemiological research that falls under the area of expertise of the Centers for Disease Control and Prevention. Unfortunately, the last comprehensive Teenage Attitudes and Practices Survey was conducted in 1989, and it was just a few months ago that the 1995 tobacco use prevalence data were released by CDCP. Undoubtedly, the tobacco industry has more timely surveillance data; public health and regulatory agencies should also have current and comprehensive information. It would therefore appear critical to ensure that CDCP be provided both the mandate and resources to conduct or contract for the conduct of such research.

(3) What are the advantages and disadvantages of pursuing tobacco product regulation using existing FDA drug and device authorities?  

There are major advantages; the disadvantages are manageable.  

First, FDA is on strong scientific grounds for this approach. Because of the probability of resistance and legal challenge from the tobacco industry to proposed and future regulatory efforts by the FDA, the FDA will constantly need to assert the scientific basis of its actions.  

Second, the FDA has extensive experience and precedent for evaluating drugs and devices. This will be critical to give it the flexibility to respond to ongoing and future issues posed by the development of new tobacco products, and the probable continuing discovery of medical and health issues posed by existing products.  

The major disadvantage would appear to be the conventional FDA requirement of safety and efficacy. However, the reality is that all drugs and devices are evaluated with respect to public health impact. Thus, drugs and devices are routinely approved which may pose health hazards to some but benefits to others, and/or because they may pose reduced risk than prior products. It does appear, nonetheless, that the approach of the ENACT recommendation to replace the 'safe and effective' standard with a standard for 'reduced overall health risk' would be a viable strategy to address the reality of tens of millions of people using tobacco products for decades to come. We need to address their needs and to minimize their harm, whether or not they are able or willing to completely abstain from tobacco. Even FDA has argued against prohibition per se, but retaining FDA's ability to reduce the risk of products without enabling tobacco companies to undermine prevention and treatment efforts is critical. An example of undermining treatment and prevention efforts is making health claims such as 'lower tar' or 'additive free.' It is not clear to me that any such claims should be permitted for tobacco products. But certainly, the making of such a claim should require that the companies had a priori submitted data along the lines of a New Drug Application approval process. Furthermore, if satisfactory data confirming exposure reduction were confirmed by FDA, then it would still be critical to restrict marketing and labeling to prevent such products from having the unintended effect (from a public health perspective) of contributing to increased youth use, preventing cessation, and reactivating smokers who had successfully quit.

(4) What changes in the PAST Act, if any, would you recommend to ensure that it achieves the goal of improving public health?  

Uphold FDA's scientifically, and legally, supported authority to regulate tobacco products as devices and nicotine as a drug.  

Extend FDA's authority to all tobacco products, including, for example, cigars. This would require the cigar industry to argue why it should be exempt from FDA oversight as opposed to burdening the FDA with the enormous scientific, legal, and administrative requirements of attempting to extend its tobacco rule to cigars, other forms of existing tobacco products, and future tobacco products.  

Affirm FDA's authority to appropriately regulate all tobacco products and nicotine delivery systems based on the nature of the products and scientifically-based assessments. The current system allows tobacco companies to simply market products as diverse as the fiberglass, aluminum, plastic device called Eclipse as a cigarette, whereas a conventional pharmaceutical company could not market such a product regardless of whether or not it made health claims unless it had obtained prior approval from FDA.  

Expand the range of agencies that will be given new and/or expanded mandates and funds to conduct research, recognizing that various agencies have strengths that are not matched by other agencies (e.g., CDC has unparalleled surveillance and epidemiological capabilities; NIH has unparalleled basic and clinical research capabilities and the ability to fund organizations as diverse a the American Health Foundation, universities, and community centers; and FDA is the only agency which understands and could direct research appropriate to enable rational regulation of tobacco products and it has appropriate enforcement experience).    

General Conclusions:

The PAST act has many strong features that could greatly contribute to the long term health of our nation. However, it should be modified to support the ability of FDA to use its authority and expertise to regulate tobacco products as combination drug and device products. This would appear to enable more effective oversight and control of existing tobacco products, as well as provide a stronger basis for regulation of future tobacco products. Requiring the FDA to develop a new type of regulatory authority and/or to require congressional involvement in regulatory decision making could be costly with respect to American lives. Similarly, tobacco companies should be subject to at least as stringent oversight as traditional drug and device companies in their ability to launch new products. The current ability of tobacco companies to launch ever more sophisticated devices such as the Eclipse nicotine vaporizer, to launch deceptive new products like Marlboro Ultra Lights, and to make apparently unfounded claims such as the 'additive free' claim of Winston cigarettes, without the prior submission and approval of scientific test data, is the hallmark of what is currently wrong with tobacco product regulation and of what needs to be corrected by Congress. Our nation requires an FDA with the full range of its scientific and legal authority, especially when one considers the dismal track record of the tobacco industry in being unwilling to be forthcoming with its knowledge of the health effects of its products and its apparent disregard for the health effects on its consumers.  

We also need to recognize that, over the next few decades, millions of current cigarette smokers will prematurely develop debilitating diseases and die. Much of this tragedy could be prevented by providing greater access to existing treatments and greater restrictions on the nature and use of tobacco products. Still more progress can be made by ensuring solid regulatory authority over tobacco products and committing our nation to a consistent course of research aimed at ever more effective strategies and approaches for preventing and treating nicotine addiction. These issues, needs, and challenges face us whether or not Congress can agree on 'comprehensive settlement' legislation. The important regulatory and research provisions should not be held hostage to a debate over tobacco industry liability issues.  

Finally, when it comes to issues of regulation of the tobacco industry, I hope that if we err it will be on the side of more stringent controls and oversight, with the goal of effectively meeting the current and future challenges posed by tobacco product development and tobacco product use. Affirming and extending FDA's authority, mandate, and resources is one clear way to accomplish this. Erring on the side of trusting the tobacco industry, for example, allowing them to make implied health claims such as 'low tar' and 'additive free,' makes no sense in the face of the industry's past record and the highly toxic nature of its products.

Public Policy Action Network (PPAN)
Public Policy Office
American Psychological Association
750 First Street, N.E.
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JACK E. HENNINGFIELD, Ph.D.

Associate Professor
Department of Psychiatry and Behavioral Sciences
Johns Hopkins University School of Medicine
Vice President
Research and Health Policy
Pinney Associates
4800 Montgomery Lane, Suite 1000
Bethesda, MD 20814-3433
(301) 718-8440; Fax: (301) 718-0034
jhenning@pinneyassociates.com

Vice President, Research and Health Policy
Pinney Associates  

President-Elect
The Society for Research on Nicotine and Tobacco    

Dr. Henningfield is an Associate Professor of Behavioral Biology at the Johns Hopkins School of Medicine in Baltimore and Vice President for Research and Health Policy at Pinney Associates in Bethesda, Maryland. Until August 1996 he was Chief of the Clinical Pharmacology Branch of the National Institute on Drug Abuse (NIDA). During his tenure at NIDA, Dr. Henningfield conducted research on the effects of a variety of psychoactive and dependence-producing drugs in human studies aimed at further understanding of the addictive process, its etiology, and treatment. He served as a Scientific Editor of the 1988 Surgeon General's Report: Nicotine Addiction and contributed to several other reports of the Surgeon General and NIDA on the topic of nicotine dependence. Dr. Henningfield has published more than 200 articles, book chapters, and reviews on the addictive effects of alcohol, morphine, marijuana, barbiturates, cocaine, and nicotine. In addition, he has received awards for his work on nicotine dependence from various organizations, including the World Health Organization, the Office of the Surgeon General, the American Society of Addiction Medicine, and the Alton Ochsner Foundation.

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