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SMOKING AND HEALTH ISSUES AUGUST 21, 1989 CONFIDENTIAL ATTORNE¥-CLIENTMEMORANDUM CONTAINING OPINION AND IMPRESSIONS OF RETAINED COUNSEL

TABLF. OF CONTENTS INTRODUCTION ......................... 1 THE SCIENTIFIC DEBATE ON SMOKING AND HEALTH ......... 5 SMOKING AND' ADDICTION ..................... 60 THE NONSMOKER: ENVIRONMENTAL TOBACCO SMOKE .......... 76 PRIOR TOBACCO INDUSTRY POSITIONS ON SMOKING ANDHEALTH 9¸0 CONFIDENTIAL 10125996 - i -

INTRODUCTION The controversy over the claimed health effects of smoking is as old as the practice of smoking itself. There is no publ~ic health topic that has received as intense and prolonged scrutiny by the Congress, various federal agencies, the medical profession, and the press as has the issue of smoking and health. Smokers and non-smokers alike have been inundated with information about the health risks associated with smoking. The Surgeon General's Office, for example, in addition to releasing its well-known annual report dealing with health issues associated with. tobacco use, has for the last several years been pursuing a highly publicized campaign directed toward school-age children to achieve a "smoke free society" by the year 2000. Every pack of cigarettes sold in this country for the last 23. years has borne a Congressionally-mandated warning label. For the last 17 years, this same warning has appeared on all cigarette advertising. Yet the scientific evidence that smoking cigarettes (and other forms of tobacco use)~ causes cancer, heart disease, and other chronic illnesses is not so one-sided as is often claimed. Reputable independent scientists over the years have questioned the validity of the various charges made against smoking. Brown & Williamson. and the other major cigarette manufacturers have consistently maintained, with. considerable support, that it has CONF ]DENT IAL

not been proven that smoking causes any chronic disease. The industry's position is often misunderstood to be that smoking has been proved not to cause any disease. This is not the industry's position. The ~ndustry believes that the question, is still unanswered. This is not to say that Congress has acted inappropriately in continuing its scrutiny of the "public health" aspects o~ smoking. The "standard of proof" in a public health sense is quite different -- and rightly so-- than that required by science, or that mandated in. a courtroom. Particularly where the question is whether the public has sufficient information about a particular product, the government may decide to act before the scientific "case" regarding the product is complete. Many products carry with them claimed health risks-- butter, eggs, red meat, and milk are familiar examples. Many other products carry known health risks -- automobiles, knives, and whiskey are again familiar examples. The public awareness as to the claimed risks of these products is much less than that with regard to cigarettes. Moreover, with the possible exception, of alcohol, no product other than cigarettes has been subj~ected to as vehement and concerted an effort to restrict or deny its availability to the adult consuming public. Thus, the use of ~ONF |'DENT |AL - 2 -

cigarettes in light of this awareness (and in the face of this effort) is uniquely a ma£ter of personal and informed choice. Brown & Williamson and other cigarette manufacturers market their product for adults precisely because the question of whether to smoke is one based on an informed personal choice. The industry recognizes that the consumer has a great deal of negative information through which he or she must sort in making the decision to smoke. Because this topic has been so thoroughly and publicly canvassed,. Brown & Williamson does not agree with those opponents of smoking who wish to place greater restrictions on the availability of cigarettes -- those who wish to make the adult consumer's choice for the consumer, in the mistaken belief that only the choice not to smoke can be "right" for any individual, no matter how well informed he or she may be. The road down which some anti-smoking advocates wish to take American society is dangerous. Once the government begins to ban "life-style choices," it is impossible to predict where it will end. Who will draw the line dividing those products and activities that are "healthful," and thus "permissible," from those that are claimed to be "unhealthful," and thus "forbidden?'" More fundamentally, what will happen to the quality of life for members of such a society, under the heavy hand of such extraordinarily intrusive government action? CONFIDENT IAL

The following material outlines some potential topics for discussion should Brown & Williamson. determine to pursue a program of legislative contacts. This program would be designed to. provide governmental decision-makers with an understandingand appreciation. of Brown & Wi~liamson's position on smoking and health. At the same time, Brown & Williamson would acknowledge its understanding of positions Congress has taken. CONF ];DENT IAL - 4 -

THE SCIENTIFIC DEBATE ON SMOKING AND HEALTH CONFIDENTIAL - 5 -

Although it is assumed by many people, and often asserted by anti-smoking advocates, that the scientific community has long: been unanimous in concluding that smoking "causes" various diseases, the fact is that respected scientists have stated that the question of whether cigarette smoking causes disease remains unanswered. The passage of time has not diminished the flaws in the case for causation; many of the reasons for skepticism that were cited by scientists in. the 1950s and 1960s are sti~l valid concerns in the 1980s. At the same time, Brown. & Williamson and the other companies in the industry have behaved responsibly in funding substantial research efforts by independent scientists into the wide-ranging issues of "smoking and: health." Those efforts -- as described below -- have not always resulted in findings favorable to the industry. Much of that research -- favorable and unfavorable -- has nonetheless been published. CONFIDENT IAI. - 6 -

THE NATURE OF THE SCIENTIFIC EVIDENCE ON SMOKING AND HEALTH. A. Lunq Cancer i. Epidemioloqical Data The most important scientific part of the industry's critics' case is the various epidemiological studies associating cigarette smoking with certain chronic diseases.1 A number independent scientists, however, have expressed concern about the interpretation of such epidemiological data. These scientists have been unimpressed by the numbers of such studies,, because of concern about the underlying validity of the evidence. For example, in the early ~980s, Dr. Laurence Kupper, in criticizing many of these studies said: i. These studies have two primary methods of approach: retrospective and prospective. A retrospective study selects a group of lung cancer patients, then tries to backtrack in time to determine smoking histories. A prospective study identifies a specific group, determines their smoking habits, and then observes the disease patterns that develop. Both types of studies then arrange the raw data into various categories, and run statistical tests to determine if one group (smokers) differs from another (nonsmokers) with respect to a particular disease. These studies have generally shown that smokers are more likely to get lung cancer than non- smokers. Approximately 90% of lung cancer cases are smokers; less than 5% of smokers, however, get lung: cancer. CONF ],DEN] ],AL - 7 -

The main. prospective (i,.e., follow-up) studies concerning smoking and its relationship to mortality and morbidity from certain diseases (as discussed in the latest Surgeon. Genera~ reports) d~o not address the issue of causality. The claim that the conclusions reached are 'impressively uniform and consistent' does not mean that a causal relationship has been established, but only that approximately the same observed associations keep appearing. I_~n fact, the biases inherent in these studies preclude the riqht to claim that causality has been demonstrated. Actually, one could arque that the same associations keep appearinq because the same biases are present in each study. The fact that so: many studies have produced a positive association between smoking and lung cancer has led many people to make the false conclusion that 'quantity means quality.' The truth of the matter is that repeatability (!i.e., the ability to produce the same estimated association) does not imply accuracy (i.e., the ability to produce a valid estimate of the true association). In this regard, one study free from all bias and producing a valid measure of the true smoking-lung cancer association is worth more than a thousand biased studies, all of which provide the same distorted estimate of the true association.. (I) And, a recent editorial in the International Journal of Epidemioloqy suggested the following: CONFIDENT ]AL We trust that the global differences in cancer incidence will finally be explained by the interplay between the environment and our genes. Thereby, it is certain that molecular biologists will have to face the challenge to help explain these variations in. incidence. A question remains whether cancer epidemiology, and maybe epidemiology in general, will have to fall to the same leve~ of academic disrepute as miasma - 8 -