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Document R1561_87

Date: 11 May 1987
Length: 82 pages

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Abstract

Page 55 of this lengthy document (labeled Bates No. 301150924) introduces the INFOTAB ETS Project. The document proposes that the global tobacco industry work together to mount an "internationally cohesive campaign" to fight legislation regulating public smoking. Page 55 begins,

"Environmental tobacco smoke is the subject of increasing concern worldwide. To resist the legislation that may result from this concern, the industry should mount an internationally cohesive campaign."

It continues,

"Infotab is generating a strategy for managing the ETS issue, to emphasize the doubts that have been expressed in the scientific debate about the alleged hazards of ETS... A common strategic line in many countries simultaneously will have a beneficial effect on the industry worldwide."

This document indicates that the global tobacco companies sought to to act in concert to obscure information worldwide about the health effects of exposure to secondhand tobacco smoke. The distribution list for the Infotab ETS Project document includes representatives of tobacco interests in Malaysia, Switzerland, France, Ireland, Belguim, Greece, Norway, Argentina, Australia, the United Staes, West Germany, Sweden, Canada, Finland, Zimbabwe, Brazil, Hong Kong, New Zealand, Netherlands, Denmark, United Kingdom, representatives of Rothmans, British American Tobacco, Imperial Tobacco, R.J. Reynolds, Reentsma, Philip Morris and Shook, Hardy and Bacon (U.S. tobacco industry attorneys).

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Notes

Selected from the Guildford documents by Health Canada. Selected on visit 4 (Nov 2000)

Quotes

[From Page 53]

I am attaching an outline of Infotab plans to combat the increasing publicity caused by allegations of health risks associated with Environmental Tobacco Smoke.

Member companies and NMAs (National Manufacturers Associations) are asked to contribute to this important piece of work by sending suggestions to Infotab of strategically useful arbuments that have beenused in their areas of influence...

...The Infotab workshop programme in Washingtonin October will place considerable emphasis on E.T.S.

[ED. NOTE: the Distribution List for the above memo and the mentioned "kitset" includes representatives of tobacco interests in Malaysia, Switzerland, France, Ireland, Belguim, Greece, Norway, Argentina, Australia, the United Staes, West Germany, Sweden, Canada, Finland, Zimbabwe, Brazil, Hong Kong, New Zealand, Netherlands, Denmark, United Kingdom as well as representatives of Rothmans, British American Tobacco, Imperial Tobacco, R.J. Reynolds, Reentsma, Philip Morris and Shook, Hardy and Bacon (industry attorneys).

PRIVATE AND CONFIDENTIAL

INFOTAB ETS PROJECT

Environmental tobacco smoke is the subject of increasing concern worldwide. To resist legislation that may result from this concern, the industry should mount an internationally cohesive campaign.

Infotab is generating a strategy for managing the ETS issue, to emphasize the doubts that have been expressed in the scientific debate about the alleged hazards of ETS and to place it in contaxt amongst other constitutents of ambient air. A common strategic line in many countries simultaneously will have a beneficial effect on the industry worldwide.

As further assistance to NMA's, Infotab is producing a kitset of public affairs materials for use by NMA's when addressing the issue of ETS. This will be presented in the form of a "Campaign Guide" which will include resources such as leaflets on the main sub-issues related to ETS and advice on ways to use such material later after it has been adapted to local conditions.

Amongst the resources included in the kitset will be a video produced specially for opinion-leaders. This will outline the main arguments and contain short extracts of interviews with scientific experts of international standing...

The Campaign Guide will first address six sub-issues (others may be added as the situation develops):

--ETS and its effect on health --ETS and its effect on women, children, babies and the foetus, --Smoking at work --Smoking in aircraft and other forms of transport --Smoking in restaurants and other parts of the hospitality industry --The contributions of ETS to ambient air quality

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Page 1: R1561_87
.-- Smokir~ and Leukaemia A study was recently published in the British Medical Journal (L J Kinlen, E RoBot. Leukaemia and smoking habits among United States veterans. British Medical Journal 297: 657-659, 1988) examining the possible existence of an association between smoking and leukaemia. The study claimed that smokers were I.$3 times more likely to develop leukaemia than non-smokers. In two particular types of leukaemia, monocytic and chronic and unspecified myelozd leukaemias, the relative risk was alleged to be 1.93. The association was also reported to be dose-related. In the same issue of the journal, Professor Nicholas Wald (an ex-student of Sir Richard Doll and a member of the UK Independent Scientific Committee on Smoking and Health) wrote an editorial on this subject. His conclusion was as follows: "Whatever the mechanism, the balance of evidence suggests that smoking may cause leukaemia. This cancer can now be added to the list of tobacco-related causes of death summarised by the World Health Organisation, including it along with diseases such as bladder cancer in category 'disease for which the excess mortality in smokers may be partly or wholly attributable to smoking-" The following points should be noted:- Professor Wald's suggestion that leukaemia could now be added to the list of tobacco-related causes of death is inconsistent with a large section in which he discusses the possibility that the claimed association between smoking and leukaemia is not causal. This highlights the somewhat arbitrary and unscientific approach that may be adopted when deciding which diseases are placed on tobacco-related lists of the WHO and similar organisations. The Surgeon-General. in his 1982 report: "The Health Consequences of Smoking: Cancer" did not even consider leukaemia in his list of cancers that have been associated with smok:ng. The authors of the study note that "ieukaemia has in general not been regarded as a malignancy related to smoking." Relative risks of 1.53 - 1.93 fall into the area of low risk epidemiology. Since many eminent epidem~ologists who are opponents of the tobacco industry have suggested that a relative risk of this magnitude is likely to be artefactual and a result of bias or error, then no conclusions can be drawn based on this result. Similar criticisms of conclusions drawn from low-range relative risks are made in connection with studies on environmental tobacco smoke. Even if one accepted the claimed association to be valid, there is no evidence that it is causal; Professor Weld notes that "Associations with a relative risk of about I°5 may be due to an indi[ect association: smoking itself may thus be associated with some other (confounding) factor that is itself associated with ieukaemia." Stu=ies claiming to observe an association between smoking and ieukaemia are very few. The relative risk that is reported in the present study, which is the biggest to date, is small enough that it Is possible ~hat the alleged association is artefaetual or a result of b:as in the study. It is also important to note that epidemiologioal studies cannot prove causation, and no mechanism is known by which smoking could influence the development of leukaemia. Dr Sharon Boyse S~/.~H 20 Sepzember !9~8 rgD CS~ f_D C~J C_D BATCo document for Legal Services • Health Canada 29 November 2000
Page 2: R1561_87
~vical Cancer A number of articles appeared in the British press at the end of last week, discussing a study published in the Lancet relating to smoking and cervical cancer. The study referred to was:- S S Barton, P H Maddcx, D Jenkins, R Edwards, J Cuzick, A Singer. £ffect of cigarette smoking on cervical epithelial immunity: a mechanism for neoplastic change? The Lancet, September 17, 1988. The argumentation used in the stud)" is as follows: They assume that there is a well-established statistical association between smokie4 and cervical cancer based on epidemiological studies. They also assu~e that the immune system plays a major role in the causation of cervical cancer i.e. that there is a lowered immune response in women who develop cervical cancer, and that because this protective system is diminished it is easier for cervical cancer to develop. Some studies have suggested that a virus (human papilloma yirus) is a major cause of cervical cancer° Since the immune system plays a major role in ridding the body of viruses, it is assumed that if the efficiency of the i~mune system were in some way diminished, then the virus will have more chance of taking hold and leadtn~ to cervical cancer. The authors went on to investigate the presence, in the cervix, of cells that are believed to be important in the functioning of the immune system (Langerhans cells). The number of Langerhans cells present in each individual was then correlated with the number of cigarettes smoked° The authors claimed that there was a dose - response relationship between the number of Langerhans cells present in the ceFvix and the number of cigarettes smoked. They claimed that smokers had fewer Langerhans cells than non-smokers. The authors interpret this finding as evidence that smokers have a reduced capacity for producing a protective immunological response in the cervical area, and that therefore their chances o~ developing cervical cancer may be increased. The following points should be borne in mind when considering the resuits of this Stud>':- The CS Surgeon-General, in his 19~2 Report "The Health Consequences of Smoking: Cancer" dre~ the following conclusions: "There are conflicting results in studies published to date on the existence o~ a relationship between smoking and cervical cancer% further research is necessary to define whether an association exists and, i£ so, ~he£he[ that association is direct of indirect." It was therefore the view of the US Surgeon-General on the basis of epide~io!ogical studies in existence at thal time (and there have beeB no s~&nificant studies since) that an association between smoking and cervical cancer has been established. C) C.D C~ "-4 .... - .=o _ BATCo document for Legal Services : Health Canada 29 November 2000
Page 3: R1561_87
There have been investigators who despite the views of the $urgeon-Generai, have claimed the existence of an association between smokin8 at cervica£ cancer. However, even these investigations ba~e .recognised that this claimed association may be due to unknown confounders: for example, cervical cancer is known to be associated with early exposure to, and subsequently high Levels of., sexua£ intercourse. It has been suggested by some investigators that smokers are more sexually active and that this is the foundation for an artefactual association between smoki~ and cervical cancer. There are s~sy risk factors for cervical cancer for which the claimed association is considerably more robust than that claimed for smokir~ e.g. age at ficst pregnancy, number of sexual partners, infection with human papilloma virus. The extent to which immune factors are critical in the development of cervical cancec has not yet been established. The authors mention that they are also £nvestigatir~ the effect on cervical cancer of exposure to environmental tobacco smoke. However, since no statistica£ association has been established to exist for active s~oking, it is even less Likely to be measurable in the case of passive smoking. ~he study reported in the Lancet did not directly address the question of the alleged association between smoking and cervical cancer. The US Surgeon-General did so in 1982 and concluded that no firm association has been established. In the absence of such association it is not possible to dec~de whether the reported observation that smokers have fewer Langerhans cells has any bearing at all on their likelihood of developzng cervical cancer. Dr Sharon Boyse SB/~ 20~h September 1988 Q c~ F'J BATCo document for Legal Services • Health Canada 29 November 2000
Page 4: R1561_87
NOtes o~ "ETS - Ind~Ltrv Interface M~etinz", $~. James' .CourtJt.HH, ot~L~ 17 Jun l~_j~88988. This meeting was organised by Don Hoel of Shook, Hardy and Bacon to occur during the same week as the Imperial College Conference on indoor Air Quality organised by Professor Perry. Members of the industry from the USA, Canada, tiE, Germany and Japan were invited, and the stated objective of the meetinE (see attached agenda from Don Hoel) was as follows:- "To briag together industry scientists to discuss scientific research and strategies on iTS and how these relate Elobally". 2. A brief description of the contents of the meeting follows. However, there were several fundamental problems with the meeting as a whole:- (i) There were far too many delegates, particularly ~rom the UI<. (ii) Nobody knew exactly what the meeting was intended to achieve, other than exchange of information on events in different parts of the world, and everyone seemed to be expecting sore than this, (ill) There were fundamental differences in approach between many of the scientists, lawyers and public affairs members of the meeting. Io some companies or markets this no longer presents a problem; however, many European scientists (e~ Dr. Adlkofer of the German Verband) are clearly unused to the unique way of looking at science that A~erican lawyers have developed. With this kind of problem of basic philosophy, there was no way that the m~eting could have been expected to achieve anything. (iv) There was also a strange mix of delegates from another point of view: some delegates represented industry manufacturers' associations (eg TAC, TI, JTI, Verhand); other delegates represented companies that operate only in one market (eg Imperial Tobacco and Gallaher, UK; Austrian Tobacco) and other delegates represented companies that are used to thinking on a more global scale (BAT, PM, RJR). For the latter companies a global approach is essential; for the former delegates it was merely interesting but not particularly relevant. Again, this inevitably led to problems of approach and objectives. 3o At the end of the meeting Don Hoel asked for opinions as to whether the meetin~ had been useful, whether additional meetings should be held, and if so, at what intervals. A number of opinions were expressed ranging from Oskar Stuhle (RJR German)') ~ho thou~ht such meetings were excellent things, to Tom Osdene (PH USA) who appeared to be at variance with his colleagues in Switzerland in believin~ that such meeti~s were largely a waste of time because it was not possible to set priorities with such a larse variety of people present. PM US & Europe seemed to be at variance on a number of issues; Tom Osdene apparently did not like Helmut Gaisch's 'white coat' strategy of ETS (see previous note on PM'S ETS strategy) and was convinced that the Centre for Indoor Air Research in the USA was the only way forward. In any event, no decision could even be formed about the future of similar meetings, and the meeting broke up in some disarray. CD CD --4 BATCo document for Legal Services " Health Canada 29 November 2000
Page 5: R1561_87
- 2- 4° In spite of the large number of companies and organisations present, the meeting was Largely Philip Morris-driven, and constant reference was made by both sets of lawyers (from Shook, Hardy & Bacos and Covington and Burling) to what PM had been doiug. Since both Stoups are deeply involved in PH's ETS strategy, this is perhaps not surprisi~. CO. Mr. N.B. Cannar ) Hr. A.L. Heard ) Millbank Mr. R.L.O. Ely ) Dr, R.E. Thornton ) Dr. R. Binns } Dr. R.R. Baker ) Southampton Dr. C.J. Proctor ) Dr. P.J. [)unn Mr. R. Sachs Imperial Tobacco, Montreal - B&~, Louisville Scientific Research Group:- Dr. C.J.P. de Siqueira - Souza Cruz Dr. S. Massey - ITL Mr. E. Kohn - BATCF Dr. J.G. Esterle - B&W Dr. G. Smith - BAT UK&E Mr. T. Wilson - WD&HO Wills CD C.D CO BATCo document for Legal Services : Health Canada 29 November 2000
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-3- ~National and International Activities an~. (i) EEC Presentation made by Dr. A.J. Nelmes of Gallaher. Dr. Nelmes described the Independent Scientific Committee's Fourth Report, the Health Educatisn Authority's educationaJ campai@ns, and the Department o[ Health's annual report. G ERHA.~%": Presentation made by Dr. F. Adlkefer of the Verband der Cigarettenindustrie. Dr. Adlkofer noted that the social acceptability of smoking is a major problem, particularly in light of the EEC's 'Europe Against Cancer' Campaign and the difficulties in putting together a coordinated strategy against this. At this time the response of the German government was unpredictable. (ii) US.% Presentation made by John Rupp of the law firm Covington & Burling. Mr. Rupp noted that the ETS situation was still dominated by the Surgeon - General's report and the National Academy of Sciences report in 1986, and that the conclusions of this report were still continually cited. Bowever, ~988 had been a good year legislatively, in that on a state level legislation for 1988 was now over, and no statewide measures of any significauce, and few at a local level, had been introduced. The most negative legislative development was the action by the US congress to ban smoking on flights of less than 2 hours. Effort was now directed at ensurin~ tha£ this measure was not renewed after its 2 - year period. Mr. Rupp believed that the major threat in the US was not legislative but attitudinal i.e° social pressure. The followin~ were noted as potentially significant:- - California, proposition 65: ETS has been listed by the scientific advisory panel as constituting a significant risk; effort has been made to resist this classification. However, the terms of the bill require that only a general warning is required to be posted in environments where listed chemicals are to be found i.e. ETS would not appear on the warning notice. - The Environmental Protection bdency were considering ETS in the context of indoor air quality, and looking at developing material against smoking. No significant developments were thought to be imminent, and the US industry was tryilig to work with the agency. US Congress was considering general legislation on air quality. However, it was believed that the Reagan administration does not support this and that therefore it is unlikely to be approved this year. The Department of Transportation was studying air quality aboard co~ercial airlines as a result of the 2 - hour ban. Proposals for work were to go out to scientists. With the continuing deterioration in public attitudes, the Centre for Indoor Air Research (Tom Osdene) and the Tobacco Institute (John Lyons) were trying to put forward a more balanced approach. C~ ~_~ GO BATCo document for Legal Services : Health Canada 29 November 2000
Page 7: R1561_87
(iii) Elsewhere JAPAN - presentation from the Japan Tobacco Institute. The Ministry of Health and Welfare had set up an expert committee in March 1986 and had written a Report reviewing foreign and domestic literature on smoking and health in March 1987. The co~ittee intends to offer non-smoking guidance. - The Ministry of Labour in July 1987 had set up a panel to consider smoki~ in the workplace; a report was expected to be issued soon° The Ministry of Education in June ~986 produced a handbook on health guidance on non-smoking. The Ministry of Finance in April 1988 set up a scientific sub-committee to consider trends in smokin~ and health abroad and in Japan. The 12th World Conference on Smokin~ and Health held in Tokyo in 1987 specifically mentioned iTS in its Recommendations. - The Japanese Society of Public Health established a Committee on smokin~ in 1987 to review the literature. The Tokyo bar Association in 1987 proposed to the government to restrict smoking in public places. - Japan Air Lines have increased their non-smoking seats, as have internal Japanese airlines. - Smoking is banned ia the undergrounds, including Tokyo. - Workplace - few companies have totally prohibited smoking, but this is increasing. CANADA - presentation by Dr. P. Dunn, rmperial Tobacco. Canadian manufacturers have set up a task force to p~omote the reality of iTS as a minor component, investigating in new scientific data and concentrating on smoking in the workplace. The Toronto city by-law asainst smoking rivals the New York ban in its scope. One person in any environment can require smokin~ to be banned. 2 bills had recently been passed in the Federal House of co~ns: CS~, ban~in~ advertising, and C20&, a private members bill reKulating smokin~ in the federal workplace; the hazardous products act is amended to include cigarettes. C~ ~7 c_~ C~ C~ BATCo document for Legal Services • Health Canada 29 November 2000
Page 8: R1561_87
- 5- Sess~o. 2, ~trv R~search_apd,Ob~ec/j~v~.~ (i) L~: Presentation by Dr. A. Nel=es, Gatlaher. strategy ~as as follows:- Tobacco Advisory Council To naintain doubt about the science to put iTS in its proper perspective in relation to air quality to dissociate perceived distaste from the health focus. Its objectives were as follows:- To 'create marketable science' [NB this latter phrase caused a considerable amount of controversy, and most scientists insisted that a given piece of research is 'created' because there is a scientific need to do so, and then °marketed'; it is not 'created' ~ it is inherently more 'marketable' than another piece] to deflect criticism to cast doubt. TAC was concentrating on the follouing areas:= To show that aggregating equivocal and inherently deficient epidemiological studies cannot lead to an unequivocal conclusion misclassification of smokers as sob-smokers in epidemiological studies other airborne substances. TAC was proposin~ to carry out the following studies:- An office environment sick building study, with Gray Robertson/ACVA a study on volatile organic substances in the workplace (someone in Birmingham). G ERMANY: Presentation by Dr. Kluss, Austrian Tobacco. The presentation centred around a conference 08 ET$ orsanised in Vienna for the benefit of the health ministry, at which a number of Austrian and foreign scientists had been invited. The meeting had apparently been a sreat success; particularly evident had been controversy between epidemiologists and toxicologists in the ETS field. (ii) us__~A Presentation made by Tom Osdene, Philip Morris (USA). The presentation centred around the Centre for Indoor Air Research and their aims (see previous notes on PM ETS strategy). He seemed to believe that if one could point out enough flaws in Hirayama's data, then the data base would go away and so, therefore, ~ould the issue. However, such an approach fails to account for the many studies published since Hirayama's original paper. CD C_D CJ --.Q BATCo document for Legal Services • Health Canada 29 November 2000
Page 9: R1561_87
.,../ -6- Mary Ward, a RJR lawyer attached to their iTS group, and Mary Potoff, Corporate Affairs PM Europe were requested to give some detail on the airline studies that have recently been carried out. Other airlines had been, or were to be, approached e.g. SA$, Varig, Finnair. C~ADA - Presentation by Dr. P. Dunn, Imperial Tobacco. The aim was to set up a Canadian database for iTS issues, since much of the data currently used in Canada h~d been generated abroad. The Canadian industry had been working with the tobacco institute to identify expertise in the area. It was also intended to set up an Indoor Air Quality Research Centre, hopefully with other interested industries. JAP.~ - Presentation by the JTI. The JTI has a Smoking Research Foundation to carry out research, and central research laboratories measuri~ environmental smoke. A copy of summaries of 10 projects supported by the JTI is attached. C~ C_D CO (DO BATCo document for Legal Services • Health Canada 29 November 2000
Page 10: R1561_87
- 7- Session 3. Scientific Informatiqn. and Media Objectives and..&ctivities ( i ) EE__CC UK First presentation by Dr. R.E. Thornton, BATCo, The following points were made:- (i) That care had to be taken in the dissemination of unpublished data to interested parties: for example, Peter Lee's presentation to the Independent Scientific Co~ittee of his unpublished results on misclassification, was very rapidly followed by a publication on this subject from Professor NJ Wald. (ii) That care also had to be taken when contributing to, or organising, scientific conferences on ETS. These conferences were not always perceived to be credible, re the conference at Imperial College earlier in the week and this was frequently not helped by the often poor quality of presentations by industry ° funded researchers or consultants. (iii) That particular attention should be paid to certain aspects of toxicology e.g. the use of DNA adducts by some researchers a~ ~arkers for subst~ces like k"TS. This should be anticipated. (iv) A lot of attention should be aimed at providiv~ journalists with information. The second presentation was made by Clive Turner, Public Affairs Director of the Tobacco Advisory Council. Mr. Turner believed that science was now takir~ second place to irritation/public opinion/"the perceived wisdom". He presented a n~ber of advertisements that TAC have issued in the national press criticisir~ bans on smoking in public places etc. GERMA~" - Dr. Adlkofer made the presentation. His opinion was as follows:- (i) (ii) (iii) No breakthrough can be expected in the analytical area, even if the work is sophisticated. Attention should be aimed at criticising the use of conventional epidemiological techniques to measure such a low risk. Biological ~onitorir~ will also become very important; this area should be studied, protective and metabolic mechanisms should be investigated, and the non-threshoLd theory of carcinogenesis should be fought, as should regulatory risk evaluation procedures. John Rupp of Covington & 8urli~ criticised this approach, saying biological monitorin~ will not solve any problems and that neither will the observation of a threshold. He seemed to believe that the industry should do its own epidemiological studies, although did not offer any suggestions as to why this might help. C_9 [/] CD Co --C BATCo document for Legal Services : Health Canada 29 November 2000

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