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Statement of John Slade, MD, FACP Regarding The Health Consequences of Smoking: Nicotine Addiction Before The Subcommittee on Health and the Environment The Committee on Energy and Commerce United States House of Representatives Washington, DC July 29, 1988 TIMN 0025641

John Slade, MD, FACP Mr. Chairman, my name is John Slade. I am a physician work- ing full-time in the Department of Internal Medicine at the University of Medicine and Dentistry of New Jersey in New Brunswick. My work largely involves the clinical and public health aspects of addictive diseases, especially those caused by alcohol and by nicotine. I treat these diseases and teach others how to diagnose and treat them as well. In addition, I am in- volved at the state and national levels in several significant public health and clinical activities regarding addiction to nicotine. It is a pleasure to have the opportunity to address your Subcommittee about some of the implications which the recent Sur- geon General's Report on nicotine addiction has for Federal policy. This is a most important report because it describes the pharmacologic reasons that the enormous epidemic caused by tobacco has been so difficult to control. Thus, this report has profound implications for public policy about tobacco as well as for clinical practice. I will first provide a clinical perspective on nicotine ad- diction (also called "nicotine dependence") and then comment on a major, current issue facing the Federal Government, that of determining the most appropriate Federal approach to the new nicotine delivery device which has been developed by the RJ Reynolds Tobacco Company. Page 1 TIMN 0025642

John Slade, MD, FACP Nicotine Addiction Over the past ten years, there has been a profound shift in medical thinking about the chronic use of tobacco. What was once regarded as merely a bad habit and a risk factor for disease has now been recognized as a primary medical problem in and of it- self: a chemical dependency upon or addiction to the drug nicotine. The recent Surgeon General's Report fully documents the data supporting this paradigm shift and carefully places ad- diction to nicotine in the context of the other major addic- tions, including those of alcohol, heroin, and cocaine. More and more physicians are coming to regard and treat nicotine addic- tion, or nicotine dependence, as a primary problem, as a disease, in and of itself, in exactly the same sense in which they regard and treat diabetes, hypertension, and alcoholism as diseases. A few milestones reflecting this shift in thinking include the recognition of tobacco dependence as a specific medical con- dition by the American Psychiatric Association in :1980, the change in name for this condition from "tobacco dependence" to "nicotine dependence" by the same group in 1987, and the Surgeon General's Report on nicotine addiction two months ago. A survey conducted last month by Ad Factors/Millward Brown, Inc. documents that the Surgeon General's Report is in no way a radical departure from current medical thinking about nicotine; rather, it is a synthesis of today's scientific knowledge about the most common serious addiction in our society today. Eighty- seven percent of the primary care physicians interviewed thought Page 2 TIMN 0025643

John Slade, MD, FACP that tobacco caused addiction (69% felt strongly that this was so), and 84% readily identified nicotine as the substance in tobacco which causes addiction (Appendix B). Natural history of nicotine addiction. Addiction to nicotine usually begins in childhood and early adolescence. About 70% of young people' experiment with cigarettes at some time, and the average age of first use is 13 years. By the lat- ter years of high school, about 20% of young people are smoking every day, and a New Jersey survey indicates that another 20% of 10th, 11th, and 12th graders are smoking at least some of the time. It is usually several years before an individual loses control of his or her tobacco use, and so the initial experience with tobacco is that it really is an entirely voluntary activity, and that a person really can "take it or leave it." About 90% of all adults who smoke began smoking as children or 'teenagers. Nicotine dependence is a pediatric disease. In her landmark studies of teenage smoking in the 1970s, Dorothy Green asked teenagers who smoked whether they would still be smoking in five years. The vast majority said that they would have quit by then. Dr. Green resurveyed these same individuals five years later: nearly all were still smoking. The Surgeon General's Report documents the fact that more than two thirds of adults who smoke would like to quit. The same is true of teenagers who smoke. A British survey reported in the industry trade journal Tobacco International found that, among 15 and 16 year olds who smoked, 68% of the males and 71% of the females wanted to stop (Appendix B). Page 3 TENIN 0025644

John Slade,. MD, FACP With the passage of time, most who smoke try to quit, but about 80% fail on the first serious quit attempt. The chances of success increase the more a person tries, and eventually, about 60% of those who have ever made at least one serious quit attempt succeed. Multiple, unsuccessful attempts to stop is normal, as it is with all other addictions. However, the experience of repeated failures tends to produce a self-image that one is hope- lessly addicted to nicotine. The Process of Quitting. When people finally stop smoking, more than 90% of them receive no formal assistance at the time of their last, finally successful, quit attempt. This phenomenon has usually been described in the literature as "most people quit on their own." This glib phrase describes what is oftent a care- fully planned effort on the part of the individual concerned. In my conversations with smokers who are trying to quit and with former smokers who have many months to years of successful abstinence, it has become clear that a lot of changes take place in the individual as he or she approaches what is finally to be a successful quit attempt. For most, the process is not one of merely laying down the last cigarette and walking away from it. It is a process born of years of frustration with and ambivalence towards smoking. A person's motivation to quit is in a constant tension with urges to smoke and thoughts about smoking. Depend- ing on which set of feelings is ascendant at the moment, the per- son may or may not actively worry about smoking or try to stop. Page 4 TIMN 0025645

John Slade, MD, FACP- As with other addictions, denial and rationalization play central roles in helping to sustain nicotine dependence. The mind makes up for the fact that smoking is out of control and cannot be easily stopped voluntarily by distorting the reality about smoking in an enormous variety of ways. Many examples of denial are documented in the literature, such as the fact that people who smoke consistently regard smoking as far safer than it is. Others are evident in the aisles of food stores, where most cigarettes are purchased: products which cover up unpleasant aspects of smoking, such as special dentifrices, breath fresheners, and air fresheners, are.sold for smokers, and special vitamin preparations are available to provide smokers with "health protection." Some of the ways in which the culture at large and the tobacco industry in particular contribute to this denial are described in an article of mine included in Appendix B. Gradually, thoughts about quitting and planning to quit may become strong enough so that a specific plan to quit is put into action. Such a plan may be sabotaged in many ways, and this leads to discouragement. However, with practice, individuals learn what it takes for them to stop smoking. Along the way, there may be formal courses or advice about quitting, nicotine gum, learning by example from friends and acquaintances, and specific experiences with illness and death caused by tobacco. All of this becomes part of the process of learning to become a former smoker. Page 5 TIMN 0025646

John Slade, MD, FACP The final, successful attempt to quit is often supported by specific environmental changes (discarding ashtrays, cleaning all clothes), and by asking for support and understanding from family: and friends. These aids may be used with or without formal as- sistance, so a casual observer may conclude that the individual who has not used any formal assistance has quit "on his (or her) own." The Surgeon General's Report reviews the literature on "spontaneous remission" in nicotine addiction and alcoholism and heroin addiction. However, the formal scientific reports do not communicate the often difficult struggle people experience as they leave an addiction behind them. For nicotine addiction, the best set of descriptions of this process may be found in a book by Raren Casey, If only I could auit, published by Hazelden. (Copies will be given to Subcommittee staff.) This book presents the personal stories of nicotine addiction and of stopping smok- ing as experienced by 24 articulate individuals. In telling their stories, these people share what it is often like to smoke and to quit smoking, and how the quality of life often improves after quitting as control is achieved over what had been a vi- cious addiction. As is true of the general public, most of these people quit without formal assistance, that is, "on their own." However, as you read the stories, you will readily appreciate that none of these people stopped smoking casually or easily. Nicotine addiction in the context of other addictive dieseases. Until recently, nicotine addiction was an orphan in the addictions treatment field. In the last few years, however, Page 6 TIMN 0025647

John Slade, MD, FACP more and more clinicians are learning to treat nicotine addiction in the same manner and often at the same time as they are treat- ing other addictive diseases. The American Medical Society on Alcoholism and Other Drug Dependencies (AMSAODD) is the major professional group of physicians in the United States devoted to treating addictive diseases, with more than 3,000 members. This past April, the AMSAODD Board of Directors established a policy which recognizes nicotine dependence as an addictive disease which should be treated as such (Appendix B). Since March 1985, the Alina Lodge in Blairstown,.NJ, a premier residential treatment program for alcoholism, has been completely smoke-free and has dealt with tobacco at the same time as other drug addictions among its clients (Appendix B). More and more drug treatment programs across the country are seriously addressing tobacco as well as alcohol, heroin, cocaine and the rest. The reason is readily apparent: while nicotine addiction has few of the major early warning signs that the other chemical addictions have -- job loss, financial distress, family disrup- tion, and legal problems -- nicotine causes far more illness and death than the other chemicals which addicted patients use. In recognition of the importance of nicotine addiction and the fact that specialists in the field of addictions need to be- come more expert in its natural history and managementy AMSAODD, in cooperation with the Minnesota Smoke-free Coalition 2000 is sponsoring a major conference on nicotine addiction in Min- neapolis in September. Page 7 TIMN 0025648

John Slade, MD, FACP The RJ-Reynolds Nicotine Inhaler Last September, the RJ Reynolds Tobacco Company announced that it planned to market a novel nicotine delivery system which it called a "smokeless cigarette." The product is actually noth- ing more than a sophisticated nicotine inhaler, and it will pose a number of serious dangers to public health if it is marketed. It should be regulated by the Food and Drug Administration as a drug since its primary use will be to initiate and sustain • nicotine dependence. This device, superficially resembling a cigarette, gen- erates heat from a tiny charcoal furnace and transfers the heat to the contents of a vented aluminum chamber containing a mixture of glycerin, nicotine and flavorants on a granular substrate. The chamber is packed in tobacco, and there is a holder on the end which the user places in his or her mouth. While this ele- ment of the device resembles a filter, it is specifically designed to not filter any of the delicate glycerin-nicotine aerosol generated by inhalation. The patent filed by RJR describes the apparatus as being appropriate for the delivery of a number of potent drugs besides nicotine. Appendix C presents the documents available to me from RJ Reynolds describing this product and the RJR marketing strategy, and Appendix D contains analyses and reactions to the product from industry and public health sources. Appendix E includes background information on the approach taken by the FDA with several other alternative nicotine delivery systems. Page 8 TIMN 0025649

John Slade, MD, FACP I will not present here a detailed analysis of why this product is not a cigarette and the narrow legal reasons why it should be regulated by FDA. These are covered in part in the ap- pendices, and others on the panel are more qualified than I to address the legal issues. Instead, I will focus on the profound public health issues which this device raises. My comments are somewhat limited because, despite assurances last September, RJ Reynolds has_not been forthcoming with impor- tant scientific information about its new product, and none of the devices have been made available to independent scientists for analyses or for independent experiments. The only scientific reports available are a series of brief abstracts which were presented at a poster session at the Society of Toxicology meet- ing last February. While these abstracts are hardly peer- reviewed scientific papers, they offer some useful information. Open publication by RJR in the peer reviewed scientific literature and presentations at open scientific conferences in which issues raised by this product can be properly debated have so far not been evident. Instead, RJR has embarked on a series of symposia to which professionals are asked to come by invita- tion only and for which members of the audience are paid for travel expenses and receive a $750 honorarium (Appendix C). This approach is repugnant to the free sharing of scientific informa- tion, especially when it involves a product with such profound implications for public health. Page 9 TIMN 0025650

John Slade, MD, FACP Potential Public Health Dangers From the RJR Nicotine Inhaler 1. The RJR inhaler may be the most addictve form of nicotine ever devised. The abstracts presented by RJR at the Society of Toxicology describe several experiments in which rats were exposed to cigarette smoke and to an aerosol from inhalers at various concentrations. Figure 1 shows how rats exposed to cigarette smoke shut down their breathing because because they find smoke profoundly irritating. In marked contrast, rats breathing the glycerin-nicotine aerosol only reduced their breathing pattern a trifling amount; the same reduction was seen in animals placed on the inhalation apparatus but only exosed to room air. In other words, the rats found the aerosol generated by the nicotine inhaler far easier to breath in than cigarette smoke, as easy, in fact, as room air. Figure 2 shows the nicotine concentrations achieved in the blood of rats exposed to either smoke or aerosol. Probably be- cause of the irritating effects of smoke, the animals breathing the aerosol achieved nicotine levels in the blood which were nearly three to five times that seen in the rats which breathed cigarette smoke. _ Novice smokers usually have some difficulty learning to in- hale because of the irritating effects of cigarette smoke. The aerosol produced by this device does not appear to cause any ir- ritation to laboratory rats, and so it is likely that teenagers would find it easy to inhale fully and achieve high blood levels of nicotine more easily than with any tobacco product available. Since the inhalation route is the most likely to cause addiction, Page 10 TIMN 0025651

John Slade, MD, FACP this pair of experiments reported by RJR suggests that the RJR nicotine inhaler is the most addictive form of nicotine ever developed. 2. The inhaler will be attractive to novice smokers. Children and teenagers commonly experiment with tobacco products, and this is how most adult nicotine addiction begins., The RJR inhaler will unquestionably be marketed as a product which reduces the risk of.using the most dangerous consumer product on the market while still providing all the pleasure and enjoyment of "the'real thing." Such a combination will have great appeal to those seeking to experiment with nicotine. Since it is so easy to use, it is likely that it will also more readily produce addiction in these same young people. 3. The inhaler will make abstinence seem a less attractive option to smokers. More than two-thirds of those who smoke want to quit, and their relative interest in quitting is in constant flux, in competition with what are perceived as the positive aspects of smoking. The mechanisms of denial and rationalization are ready-made to take advantage of the RJR nicotine inhaler. Since it will be perceived as lowering the risk of lung cancer (although not of other major categories of disease caused by smoking), many smokers will be fooled into thinking that they can continue to smoke and not suffer any consequences. This will retard the tendency to quit of the majority of those who smoke. Just as filter cigarettes and low tar cigarettes were marketed to meet consumer "concerns" about lung cancer, so, too, with this product. The tobacco industry piously pretends that Page 11 TIMN 0025652

John Slade, MD, FACP its product advertising is only aimed at helping committed smokers choose which brand of cigarettes to smoke. Two adver- tisements for another RJR 'product, Vantage, tell a different tale. Their headlines read, "To smoke or not to smoke." and "How many times have you decided to give up smoking?" The choice offered to consumers is not among various cigarettes. Rather, the choice is between continuing to smoke and abstinence. It would be exactly the same with this product. Consumers would be asked to choose between using cigarettes, the RJR in- haler, or abstinence from nicotine. There would be no explicit discussion of the substantial dangers posed by the inhaler, however (see below). A tobacco industry analyst, quoted in World Tobacco, notes that the RJR inhaler might lead to increased per capita. consump- tion among existing smokers, as well as a return to smoking among former smokers and the initiation of new use among never smokers (Appendix D). 4. The inhaler may be used where smoking is prohibited. Clean indoor air policies and laws are designed to protect the nonsmoking majority from the harmful effects of tobacco smoke pollution. While such policies are not intended to force people who smoke to quit smoking, they often help those who are inclined to quit anyway to do so. (This effect contributes to the great popularity of such policies and laws.) The Favor Smokeless Cigarette was marketed for use by people who found themselves in places where they could not smoke: it promised nicotine by in- Page 12 TIMN 0025653

John Slade, MD, FACP halation without lighting up. In February 1987, FDA declared that Favor was a drug and could not be sold without FDA approval (Appendix E). As with Favor, so, too, with the RJR inhaler: if the in- haler is used where smoking is prohibited, this product may un- dermine thoughts about quitting smoking brought into focus by clean indoor air policies. In this way, the nicotine inhaler represents a form of nicotine abuse in just the same way that a heroin addict may abuse methadone on the street to tide him or her over until the drug of choice is again available. 5. The inhaler may promote relapse to active nicotine de- pendence. Many who have stopped smoking are not stably committed to abstinence for some months to years. Relapse remains a threat for a long time.- This new product may be regarded as safe enough to use even among former smokers, even though such use .would in fact be.hazardous. The industry analyst cited above noted, "[Y]ou might bring back some smokers who stopped smoking... . m While this analyst may approve of such a prospect, this pos- sibility is genuinely alarming to those concerned with health. Unfortunately, there is no way to predict how much of a problem this would be short of unleashing it onto the market for several years. 6. The inhaler will be directly toxic in several important ways. While use of the inhaler may well be associated with a lower risk of lung cancer than smoking cigarettes, the product is far from safe. Smoking causes more deaths from heart disease than from lung cancer, and this product contains both of the Page 13 TIMN 0025654

John Slade, MD, FACP poisons from cigarettes, in similar concentrations found in cigarettes, considered to cause- heart disease: -carbon monoxide and nicotine. These same chemicals are also implicated in the damage which cigarettes cause the fetus. A detailed considera- tion of the toxic long-term effects of nicotine alone is found in Appendix B of the Surgeon General's Report. Thus, while one may predict that the inhaler will cause less lung cancer than cigarettes, it would have substantial associated morbidity and mortality. Considered by itself, it would be dif- ficult to justify marketing such a product at all for this reason alone. 7. The inhaler may be user-modifiable for use with other drugs. The RJR patent on the device speaks of the possible use of this invention as a delivery system for a variety of medically useful drugs. While speculative (because no samples are avail- able for testing), it is easily conceivable that this device may be modified by the user to deliver inhaled doses of other drugs of abuse, such as heroin. Injecting a drug in or near the aluminum chamber may be possible, and the user could then heat it up and inhale the drug without pyrolysis in the same manner as the device delivers the nicotine provided by the manufacturer. Summary Nicotine addiction is a major disease which usually begins •in childhood and adolescence. Since it involves more than a quarter of all adults and directly leads to more than 1000 deaths per day, it is by far the most common serious medical condition Page 14 TIMN 0025655

John Slade, MD, FACP in the United States. The recent Surgeon General's Report makes an essential contribution to the public discourse on tobacco by bringing the addictive nature of nicotine into sharp relief for all to see and understand. This report will be of equal impor- tance in shaping public policy about tobacco as the landmark report issued in 1964 by the expert committee appointed by Sur- geon General Luther Terry has been. The medical profession and most who are addicted to tobacco already know and accept the major conclusion of this report. We now face the task of sorting out its implications and acting on them. The RJR nicotine inhaler is a major challenge to public health efforts aimed at controlling the enormous epidemic which tobacco has caused in this country. The Surgeon General's Report concludes that "new nicotine delivery systems should be evaluated for their toxic and addictive effects.". The RJR inhaler is such a product, and the responsibility for conducting or supervising such an evaluation on behalf of the Federal Government rests with FDA. The World Health organization has called on its member na- tions to ban the importation or local manufacture of smokeless tobacco where there is no historical market for this product be- cause it makes no sense to complicate epidemic control with the introduction of new tobacco products. In exactly the same way, the RJR nicotine inhaler is a novel nicotine delivery system which would likely seduce large numbers of current, former and novice smokers by its appearance of high- tech and safety. The novices would be children and teenagers. The sad reality, though, is that this product is not safe, and it Page 15 TIMN 0025656

John Slade,, MD, FACP will sustain and thus prolong addiction to nicotine. In short, the introduction of this product would needlessly complicate the major gains public health officials have achieved in recent years. If introduced, the RJR inhaler will be a major setback to achieving control of the tobacco epidemic. Thank you. Page 16 TIMN 0025657

Fl Minute Ventilation Rats Exposed to Cigarette Smoke or to Aerosol from Nicotine Inhaler % of Baseline out of Apparatus 100 75 50 25 Inhaler 0 Lou Medium Test Group High Plasma Nicotine Rats Exposed to Cigarette- Smoke or to Aerosol from Nicotine Inhaler Plasma Nicotine (ng/ml) 250 200 150 100 50 MCigarette Inhal.er =Cigaret te 5 ugil 15 ugil 30 ugil Atmospheric Nicotine TIMN 0025658

Appendices A Curriculum Vitae B Nicotine Addiction C The RJ Reynolds Nicotine ]:nhaler: Company Documents D The RJ Reynolds Nicotine Inhaler: Analysis and Reaction E Related Alternative Nicotine Delivery Systems TIMN 0025659