ONOON MARCH 1988 SMOKING ISSUES COIFERENCE · I Al HEARD GROUP RgO 4CTtVITIES IW RESPOHSE 10 RECOmENDATIONS OF REL;ULATORY BO01ES Introduction In his opening remarks the Chairman has said that both BRT, from its Research activities, and independent researchers have data that challenges, or can be used to refute, simple conclusions being drawn by those bodies for whom purely scientific argunent seems of minor importance, Much of this data was gathered in response to Regulators. I shall give examples where this shows erroneous judgements are made, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 The other response, kt~ich I shall address, Is quite different, Some regulators give very clear directions for improvements in product characteristics - improvements that they deem relevant to the SIH argument and that they would wish the Industry to pursue, This, in my view, presents an opportunity · when the regulators refuse to become involved in suggesting how they would see the product Improved and simply take the stance "smoking is bad" we face a difficult scenario, I shall consider how product changes might be made in the light of overall direction from the regulators, Attitudes end Reewrmendations of Regulators Who are the Regulatory Bodies? Difficult to give a good definition but it includes those authorities, official or unofficial, that advise Government, lead to legislation or influence public opinion and hence our consumer, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 We shall examine the attitudes that have developed and the recommendations made by these bodies, The following slide 1 lists a number of recent reports frrm Regulatory Bodies, in terms of the association between active smoking and disease the Authorities accept the 'causality theory', little new has emerged in these reports, although some ~nti-sn~olring crganisations are carrying out or funding research into mechanisms of diseases such as lung cancer, The American Health Foundation, for instance has a substantial programme of research into tobacco specific nitrosamines, including their possible role in altering genetic inaterial, Under the auspices of Group RIO we fund basic research into mechanisms of smoking·associated diseases at several reputable medical departn~entsliatitutes since this research may resolve the associationlcausali ty controversy, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 The major theme, however, of the reports from Regulatory Bodies is related to Environmental Tobacco Smoke; in some It is the only thee, i, Environmental Tobacco Smoke Recent years have seen a marked escalation of the Passive Smoking problem, with extensive coverage in both popular and scientific publications, The antisoking lobby seems to have switched its attention almost totally to this subject, trading on the emotive issues of the effect of smokers on the non·snoker, The reports from Regulatory bodies in this area have drawn various conclusions about possible associations between ETS and diseases, notwithstanding the frailty of epidemioiogical techniques in this area, Two of the more unbalanced statements to have emerged from the most distinguished of Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 such authorities are shown in the next Slide 2. It is important that you are all, aware of some of the misapprehensions surrounding ETS since these are proving a source of erroneous conclusions by those pressurlslng to restrict smokers' freedom, In many studies on ETS, there is, for instance, no knowledge of dose whatsoever beyond noting that individuals are married to smokers, In other studies based on often specious information, the exposure of non-smokers to smoke atslospheres is translated into extraordinary claims Of 'eguivalent cigarettes smoked', An important source of error in many external publications sterns from the assumption that ETS is the same as SS, In fact, ETS is gulte different from SS: Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 i, ETS is a dynamic mixture of substances fo~med as a result of tobacco smoking, ii, ETS is created from SS (80-90:) and Exhaled smoke, iii, SS and Exhaled smoke are highly diluted as they form ETS and this leads to r~ny changes, We have found that: i, EiS components rise and fall with time; decay rates vary for different compounds, ii, EfS levels of Particulate matter are only 50-608 those predicted from SS yields, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 E~S nicotine is only 40450X that predicted from SS levels · and decay rate is faster than for any other component, iv. ETS nicotine is mainly in the Vapour phase · in SS nicotine is mainly in the Particulate phase, All this data goes to show how conclusions formed on SS information can be wrong, Here are two examples of Publications that confused ETS and SS: i, SS nitrosamines are 100 X corresponding values for MS, Hoffman has speculated that passive smokers are more at risk from nltrosamines than active smokers i! Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 ii, MaCtashamipur et al, have suhitted a paper for publication that comparer biological activity of condensate from MS and SS, They find SS to be slightly nore active and conclude ~.. greater biological risk caused by passive makinp than by MS smoking I!I E;S is widely portrayed as a major pollutant in demestic, working and social situations, this has been refuted by Grey who has studied the "sick building syndrome" and shown that EIS is a minor factor, lie also are gathering data to help set ETS in context: i. Background levels of CO and NO vary over 24 hr, due to traffic, industry etc, Peak background levels of tO last for 2 hr, and equate to 2 cigarettes smoked simultaneously in an average roon, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 ii, Surreptitious monitoring of atrospheres from various smoking environments - Jiving roon, kitchen, car Indian restaurant produced a general scan showing: - low cones, of nicotine (3·38ug,lm3) - nicotine was a minor component rel, to other volatile components (from cooking, polish etc,) Finally, RIR studies in US restaurants and planes show that on average people are exposed to very low levels of ETS, equivalent to smoking (1/100th of a cigarette, Sugary of ETS Objectives Slide 3 summarises our objectives for Research In the important area of ETS, ~1.. Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 nicking up on two of these we should first note that In the context of 1 b 2 we need to find reliable markets for ETS, Clearly nicotine, though specific to tobacco is a poor marker, Our sights are nov set on specific conponents of the partieulate matter, Secondly, and of considerable relevance to this meeting, we need to publish our findings, Publications The Tobacco Industry has by no means been silent on the issue of passive smoking and ETS, Firstly, within the Industry RJR in particular has shared very freely its research findings but PM and BAT are also publishing wherever possible, Slide a shows the BAT publications, We shall present the keynote paper at the forthcoming Conference on Indoor Air quality in london this year, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 The TM; ha produced special publications on the general and scientific aspects of ETS. Just this month, having seen a draft of the 4th Report of ISC, TAC called a meeting with the Minister of Health to protest the poor science and the preposed aoti·smoker line proposed by those responsible for the report. ihe question for this meeting is - how do we gain more impact from these important research findings than we have achieved to date ?? 2~ product Modifications Same Regulatory Bodies consider product modification policy successful, They conclude that lower delivery is responsible for reduction in lung cancer (ignoring eonpensatian, eanvenlently). Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 'Ihey ire now addressing further ndificationr required, Of course, not all of the Regulatory Authorities are willing to follow this course. Neither the US Surgeon General nor the American Health Foundation an prepared to pursue a line or product improvement, but in ~nada, in Gena?y and in UK there Is grewing interest in smoke components, for instance, and we can anticipate sane direction far product change emanating from these enquiries. Specific modifications either started (e.g. ISC 4th Report) or we can anticipate are: i. Mainstrean · continuing tar and nie reduction. tarlnicotine ratio reduction Slide 5 - tar quality - other nora Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 2, ETS · less sidestream Slide 6 less irritant, obtrusive Skillfully managed, product developments based an consumer demand, itself based on statements from the Regulators, can present a positive step by the company and a commercially competitive position, The success of Silk Cut in UK is a testimony to this, The question for us today is how aggressively should we respond to or anticipate Regulatory directives ? Evolution or Revolution So far the industry in general have pursued Evolutionary approach, certainly in terms of overall deliveries, To a larger extent the rate has been dictated by the willingness of the consumer to accept the changes, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 Concern has been expressed originally by Russell, that tar Is the undesirable element of smoke and that nicotine, the prime stimulus for smoking is relatively tolerable. This suggests a line of development in which tar is reduced but nicotine remains relatively high, Over the last 20 years, as overall deliveries in UK have reduced, the T/N ratio has fallen from 15:1 to 1111, Again, gradual evolution, In the case of tar quality - we still lack definition but as biological test methods improve, we may see 'light at the end of the tunnel', Other nora, the minor undesirable elements of smoke, have not been consciously altered In cigarettes to date but any cigarette modification in development that push these the wrong way are abandoned, Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 Any reduction of sidestream smoke emissions from cigarettes has, apart from one or two inltiatlver, been aceidental, thus, reductions in weight nf tobacco burned per cigarette (whether due to reduced leaf usage, incorporation of expanded tobacco or circumference reduction) will have contributed to any observable reduction, The SS initiatives by our competitors were based on the principle that visible sldesbeam can be reduced through the use of special cigarette papers. These have failed eomoercial ly~ This gradual evolutionary trend in product modifications looks as though it is about either to end at at lent to receive a sharp knock. It is not only from within the traditional industry that the challenges may come, 3 years ago, RTP attempted to launch a product that simply ,,111 Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 delivered nicotine vapour and flavourants by drawing on an unlit tube containing a special plastic plug, Just recently in US, C A Blockers, a small company, has announced its plan to launch a cigarette called Opt~M that has reduced health risks, The 8 mg cigarette has an additive N·Bloetln that blacks the action of nitrosaroines in living systems, The company is planning to license cigarette companies to use N·Bloctin, A truly revolutionary approach to those who criticise todays product is by R J Reynolds, They have announced their intention to launch a smokeless cigarette, Slide I RJR Smokeless Product The basic principle of this product is shown in Slide Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 Slide gives the background to the project as we know It, the pmject has senior cqany backing and airnr at the Iperfect cigarette' ~ Timinp considerations of the new product are sun~narised in Slide Slide shows the principll attributes of the Smakelesl cigarette. The type Of Testing protocol that RJR are pursuing with their product is shown in Slide Regulatory issuer so far identified with this praduet are sunmarised in Slide Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 I~ Response Within the Group we hive launched hvo new pmject~ project ~rbus In BIW has the aim of identifying a smokeless product jbut with some tar9etted improvements over the RJR product) by the final puarter of l9pg, Group funding of this project Is ~500~00 for 1988, If this exploratory phase Is successful, this will call for a very large cornnitment of at least 520 n. war a years to cover RfOlcapital cost to test market stage. This Is our Revelutionary approach, ihe second project Is called Greendot, This reflects the lvolutionary approach to ymLct development, ~bdt LIICI on rapid cxtrapolatlon from today's position. ~e ClibPDF - v~~fastio.soni principal objective elf Greendot ir shown in Slide . fhe t~nswler acceptability of such develapn~nts is seen as key (Jlide i. Slide shows sane Of COLBr Requirements of such a product, Group funding of this pmjeet parallels that of Airbus ad tic·rca~es are expected to he very slailar. Finally, to pull all three Innovatory products together on one Slide ,,I,~ Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111 Sua~ i. We have rounlly·barld data that challenge sme of the conclusions drawn by the Ruthoritier, particularly in the area of E1S, pU. What further data should we be seeking and How do we gain more impact from its publication ? 2. We have ideas for Revolutionary and for Evolutionary Product Oevetopment reflecting the trends set by Regulators, pU. How aggresriuely should we respond to pr anticipate in wr Product Research these trends 1 Clit; PDF -!::!!::!!::!.f3 StlC.i: 0111