ION L. c. F. e. 2 8 JAc. 1990 Draft Paper for 1980 Tobacco Division C. A. C. ACK ...... FILE ....... CURRENT ISSUES IN SMOKING AND HEALTH Undoubtedly, the most encouraging recent development in the controversy over smoking and health has been the recognition by scientific and medical authorities that modern developments in low tar delivery products imply that smokers may be exposed to a greatly reduced risk compared with that Incurred by smokers tiventy years ago. The original statements in 1976 by Dr. Gio Gori, with the endorsement he gave to sDecif ied low delivery U.S. brands, has been followed this year by a publication by Wynder and co-workers in which & brand specification for a less hazardous @roduct was listed, which went beyond Gori by giving a limit for the delivery of nitrosamines. There is also the recent press report of a statement by Prof. SchmXhl in Germany, to the effect that modern low delivery products may be smoked in moderation without any risk. The forthcoming Cold Spring Harbour Symposium (October 1979) may well be the occasion for further statements of this nature. 2. That such a development would occur became plausible when it was first shown that male mortalities from lung cancer had stabilised and were subsequently turning downwards, particularly in the younger age groups, who had been exposed to filtered products for a longer fraction of their smoking years. This was first apparent from U.K. mortality statistics. It has subsequently been noticed in the results from a large U. S. prospective survey by Hammond. Earlier, there had been indications that smokers of filter cigarettes appeared to incur less risk than smokers of plain cigarettes (Bross and Gibson; Wynder, Mabuchi and Beattie: T. R. C. North East England study); but these had been relatively small-scale surveys, subject to sizable error. In the early days of the controversy, importance had been attached by many experts to the claim by Auerbach that-, he could recognise the precancerous state of "carcinoma in situ" in the lungs of most smokers at autopsy; ea ual importance, therefore, should be attributed to a recent paper br Auerbach in which he notes the fact that this state now only occurs im a very small proportion of smokers' lungs. He suggests -that this is C=> largely because the products smoked in recent years have been 1-.0 filter cigarettes. (It is prcbAbiv too soon for the co increased consumption of lcw-delivery products to be reflected in a further change of di-cezse rate or cell state). BAT Co LTD - MINNESOTA TOBACCO LITIGATION - 2- These encouraging signs are seen in male mortality rates and it must not be expected to be found in female mortality rates yet, apart from the U.S.A. As a result of the increase In cigarette consumption by females elswhere In recent years, it is probable that female death rates from smoking associated diseases will continue to increase, although, because women tend to smoke lower delivery products, these rates are unlikely to reach the levels attained by male mortality statistics in the past. 3. Paradoxically, the encouraging developments outlined above have thrown up the greatest weakness in the controversy. For legal reasons, which are easy to appreciate, the industry s unable to claim credit for these developments or to use the results directly In any campaign to popularise the smoking of low delivery products. Indeed, while adopting an aggressive stance with the intention of offering consumer assurance, the Industry is running the danger of sharpening the controversy and thereby being forced more on the defence, just at the time that some of its long term opponents are prepared to indicate the relative safety of certain products for those smokers who are unwilling to forgo the habit. Polarisatioa of the situation has the potential of antagonising would-be allies, who have given clear indications of their willingness to say things that the industry dare not. A crucial task for the future would, therefore, seem to be finding some way out of the legal impasse. 4. In the past two years, the threat posed by carbon monoxide in scientific terms has abated. Following the public recantation by Astrup, there are no valid scientific reasons for the belief that carbon monoxide may initiate cardiovascular disease. Smoking still persists as a risk factor epidemiologically, but there are no adecuare models for testing theories of the courses of these diseases. Public authorities remain somewhat equivocal about the possible significance of carbon monoxide in smoke. it remains something of a hazard for people already suffering from the disease. Equally, measurements have shown that there is little strength to attacks based on carbon monoxide contents in ambient air. The thrust of the debate on passive smoking has turned to the arguments based on social acceptability, indicating that the anti-smoking lobby recognises the weakness of their case in scientific terms. 5. Other weaknesses in the controversy con to be the already-recognised problems associated with nitrosamines and potential allergens in smoke. Nitrosamines formation Cr_ is dependent upon the tobacco blend and is, theoretically, cc su@5ceptible to control by tobacco selection. U-4 BAT Co LTD - MINNESOTATOBACCOLITIGATION - 3- They are selectively removed from smoke by cellulose acetate filters and, consequently, the levels suggested by Wynder as non-hazardous are potentially attainable. The U.S. Surgeon General's Report stated unequivocally that tobacco smoke allergy remained unproven. Nevertheless, some workers suspect that bronchitis and/or emphysema associated with smoking may be a manifestation of an allergic response by the lung. This is a comnlex area In which there is genuine disagreement among experts, but It remains a threat. Both nitrosam nes and allergens are more important threats to the industry's position on passive smoking. The social implications of potential hazard to non-smokers are well recogntsed. The establishment of safe exposure levels to nitrosamines on the part of medical authorities would greatly clarify the position. 6. There are two smoke constituents which, in the past, have been considered relatively hazard-free, but about which new suspicions have arisen. One is the radioactive element polonium-210 (a radium-like material), which is believed to be present in the insoluble residue of smoke particulate matter. Its deposition in the lung is suspected of causing radioactive "hotspots", leading to cell mutation of malignant type. Potential risk associated with polonium has been raised at least twice in the past, latterly by Radford, but the subject has died away, because of lack of positive experimental evidence. T.-.e matter has been re-opened in the U.S.A. (I hope to learn the latest position during my visit to the U.S. in October) The other suspected constituent is nicotine, for which evidence of carcinogenic (or more probably co-carcinogenic) activity has been revealed In studies under the auspices of the National Cancer Institute and has been partly confirmed in our own extramural programme. The potential importance of this suspicion cannot be overemphasised. (Again, I hope to learn more about the latest thinking during the U.S. visit). There is, as yet, no other substance with the same pharmacological activities (both beneficial a@:d undesirable) as nicotine. It underlines the need to understand as much as possible of the ways whereby nicotine exerzs its action on the central nervous system. A theory that nicotine may C::1 mimic the wav in which a natural substance ma-- act on brain processes is attractive and it is very significant C= that Philip Morris are working with a group i-vesiigating C= this, originally under a C. T. R. grant, but ncw exclusively with Philip Morris. BAT Co LTD - NIINNESOTATOBACCOLITIGATION - 4 - 7. Despite the threat around nicotine, it is still recogntsed as being one reason, but not the only reason, for people smoking. The danger that it would be labelled a drug of addiction, differing little from heroin or cocaine, appears to be receding; although zealous anti-smokers may still pursue this idea pole=ically, authorities on addiction do not substantiate the charge. If advantage is to be won by marketing low delivery cigarettes, there will be a need to understand fully the motivations for smoking and the factors which govern the way in which cigarettes are smoked. We are well placed as a Group, in that we are in the forefront of the technique at present. S. A potential danger is that smoking by males may be incriminated as causing a genetic mutation, thereby affecting progeny. There have been one or two isolated papers alleging evidence for this recently, without any aztempt to define the alleged cause. They have passed by without being noticed. Were this allegation to be picked up by the press, particularly in counties with a strcngly-masculine outlook, it could have an effect on sales out of proportion to its significance for health. THE FUTURE There can, of course, be no guarantee t-_: an issue, hit'.-.erto unsuspected, will not be discovered and used to fashion a new weapon, to attack the industry. There seems no medico-scientifIc area, which has not a I re a been discussed; politico-economic issues lie outside this brief. The nature of the problems and opportunities foreseen in the foregoing review will undoubtedly differ in extent cr applicability, depending upon the current szate of the i For simplicity's sake, smoking and health controversy. three stages are considered:- (a) Developed countries, with a recogni-sed pattern of mortality in the smoking associated diseases. League tables of brands are most probably already published and a sophisticated public are aware of the major issues. This group covers Al. Amer Europe, Australasia. Here, there are clear incen:ives fc7 the oroduction of low-delivery cigarettes a the specifications published by Gori and Tv- .4m - accc-uanied, perhaps, by the publication of " ar@:icles :!I-a%vi ng attention to these cri teri a. _j BAT Co LTD MINNESOTA TOBACCO LITIGATION - 5- This may well be accompanied by demands for syste=s of graduated taxation, based on tar yields. The motivation behind such demands may not be the encouragement of these brands, so much as the progressive reduction of yields to zero, with the intention of extinguishing the smoking habit. Consequently, such systems should be resisted and, for this purpose, aspects of the work on smoking behaviour may be useful. While there will continue to be demands for a simplification of multi-component leiguetables, these should be resisted. They cannot be justified scientifically and they are fraught with undesirable legal implications. There is a school of thought, to which we have subscribed in the past, advocating a progressive change in the ratio of tar to nicotine, enabling smokers to satisfy their need for nicotine, while reducing their tar intake. While this procedure is plausible in changing from high to medium deliveries, there is evidence from smoking behaviour that it may not hold for the switch from medium to low delivery products and, while there exists a question mark about nicotine, it would clearly be imvolitic to stress nicotine deliveries in this context. In order to demonstrate that the change in product deliveries has led to an amelioration in health statistics, there will be a need for prospective epidemiological studies. Where possible, the national health authorities should be involved in these, partly to gain their commitment to the policy, but also to avoid awkward legal predicaments, which could arise, if the industry were too closely identified with the findings of the surveys. As mentioned earlier, a resolution of the legal imoasse in the U.S.A. would greatly assist these approaches. If we assume the policy to be successful and to result in reduced mortalities, the anti-smoking forces. are likely to intensify their attacks on social acceptability of smoking. In this case, reliance will have to be placed on concepts of individuals' freedcm and the demonstration of absence of harm in <=) smoky environments. 1_-0 C= co __J co BAT Co LTD MINNESOTA TOBACCO LITIGATION -6- (b) Developing countries with stable political environments, in which the daily per capita consumption of cigarettes by smokers Is around 10-20 and where standards of medical care are becoming available to all the population with reliable mortality statistics. This would cover the Far East and parts of Latin America. The products available here are predominantly higt tar, but with an increasing proportion of filter tip cigarettes. It must be expected that, wirn increased medical care leading to longer life and 'with an improving economic climate resulting in higher disposable income, there is likely to be a rise in mortality rates from smoking-associated diseases, just as in the case of women in Developed Countries. There will be advantages If the major products can be moved into, at least, the middle tar category and, for this purpose, changes in the ra of@ tar to nicotine would enable the change to be msde without undue loss of consumers (a replay of the U.K. situation in the late 1960' If possible, agreement through ICOSI with major in competitors might ensure that most brands were moved at about the same time. Shculd there be demands from Governments, prodded by WHU, for publication of league tables, there will be an acceleration in the demand for low delivery products and this may well occur before the publication of adverse health statistics. It would be prudent to maintain at least one brand in the low delivery category, even although it may not be sumcorted in the market. Restrictions on smoking for anti-social reasons mar be expected. more on the basis of "me -too ism" rather than because of a legitimate campaign. (C) Underdeveloped or politically unstable countries, or :hose with a large uneducated peasantry. here the daily per-capita cigarette consumption is generally so low tnat mortality statistics, if available, would not show much connection with smoking. It must be rems--bered that smoking two pre-1960 U.S. cigarettes, equivalent to 20 low delivery 1979 cigarettes, was noz associated with any increased health risk. The problems here are infant mortality, infection it a ting tropical diseases. an d deb The attack on the ind,_,strv in these circumstances has been rade on -tile basis o.C ..double standards", but this can be refuted if covering the range of deliveries are a V P. j :- 7 BAT Co LTD MINNESOTATOBACCOLITIGATION -7- Governments of these countries are likely to be more interested in the raising of agricultural standards and the revenue to be gained by taxing tobacco products- rather than In eradicating non- existent tobacco-associated diseases. DGF/AIB/1.1.1.5 24th September, 1979 BAT Co LTD - MINNESOTATOBACCOLITIGATION