OTHER RESEARCH FUNDED BY THE MANUFACTURERS

  4.49  As part of the programme of voluntary agreements on product modification, Gallaher and the other UK tobacco manufacturers provided funds to establish a major research programme, initially between 1982 and 1985. The Tobacco Products Research Trust ("TPRT") was established and registered with the Charity Commissioners in 1982 as an entity independent of the UK tobacco manufacturers. Its purpose was to administer the funds provided and to select and supervise research. TPRT funding by the tobacco manufacturers continued until 1988 and the projects so funded continued until the mid-1990s. In essence, the TPRT promoted independent monitoring research into the effect on the health of smokers of modifications to tobacco products through the reduction of tar yields or otherwise. In total, the TPRT oversaw the funding of some 37 projects, covering a range of scientific enquiries into smoking and health.

  4.50  Shortly after the termination of the TPRT, in 1996, its Chairman, Sir Peter Froggatt commented on the involvement of the tobacco manufacturers:[46]

"The industry, especially though not exclusively the companies' scientific research staff, took a healthy interest in the progress and results of the research programme, and in all ways relationships between the Trustees and the industry were amicable and constructive. This contributed greatly to the success of the programme."

SMOKE MEASUREMENT

  4.51  Prior to 1972, in the UK, there was no generally accepted standard method of machine measurement of tar yields. Such a method, with standardised specifications, was established in 1972, following extensive consultation between the tobacco manufacturers and Government, in particular, the LGC. Subject to minor modifications, that methodology has continued in use, in the UK, to the present day.[47] This standard methodology involves the collection and measurement (by weight in milligrams) of certain particulate matter[48] produced by a smoking machine which "smokes" cigarettes, taking puffs of a specified volume and for durations of defined intervals. Since 1992, Gallaher has been required by law to print onto each packet of cigarettes the tar and nicotine yields of the cigarettes contained therein using the ISO methodology.[49]

  4.52  Following the adoption of a standard method of machine measurement in 1972, the first tar tables for cigarettes were published the following year in the UK, by the LGC.[50] These tables also included nicotine yields. Cigarette brands were ranked in order of tar yield within various bands. From the outset, Gallaher produced cigarettes, among its range of brands, with the lowest measurable tar yields at that time—4mg per cigarette or less.

  4.53  It has been known for many years that the tar yield of any brand of cigarette does not necessarily correspond with the tar delivery of that cigarette to a human smoker. As the Fourth Report of the ISCSH[51] observed:

"These parameters have been criticised as not reflecting average human behaviour and leading to published yields universally under-estimating yields actually obtained by the average smoker. Critics of the machine smoking procedure have frequently failed to understand that values presented in tables published by DHSS have never been intended to be actual yields obtained by any one smoker. Rather, they enable brands to be ranked. This allows inter-brand comparison under a standard test procedure, presenting the smoker with information to enable him to choose, if he so wishes a lower yielding brand."

  4.54  There is a wealth of evidence from studies conducted by scientists that suggest smoking practices vary between one smoker and another; different people smoke differently.[52] Thus, the degree of tar delivery from a particular brand of cigarette varies from person to person and cannot be equated with the tar yield of that cigarette as measured by a smoking machine using standard parameters. The tar and nicotine deliveries that any individual smoker will receive will depend, amongst other things, on the number of puffs taken from a cigarette, the size of each puff and the rate at which each puff is drawn from the cigarette.

  4.55  There can be no specifications for determining individual tar and nicotine deliveries to the smoker, as the factors influencing them are largely within the control of each individual cigarette smoker. The numbers on the cigarette packets do, however, allow a person to make a selection between the different brands of cigarettes that are sold in the UK, based on their relative yields of tar and nicotine.

COMPENSATION

  4.56  From the late 1960s, scientists began to investigate whether smokers who changed to brands containing lower tar and nicotine levels increased their intake of smoke, an effect commonly described as compensation.53 [53]

  Compensation was also considered by the RCP in its second report in 1971[54] and in two subsequent reports.[55] The ISCSH also addressed compensation in its Third Report in 1983[56] and its Fourth Report in 1988.[57]

  4.57  By their very nature, cigarettes with reduced tar levels are designed to produce lower tar deliveries to smokers. With reductions in tar, there is an overall reduction in mainstream smoke constituents. Given the great variability in the way individuals smoke, Gallaher recognises that when a person switches to a lower tar product he or she may compensate, at least initially. The position has to be balanced against the overall desire of seeking to reduce the overall tar yields of cigarettes. Indeed this re-inforces the importance of gradual reduction.

  4.58  In endorsing overall tar reduction, the ISCSH recognised that tar reduction should be implemented gradually in order to reduce the extent to which smokers may compensate. The ISCSH realised that it would be impossible to continue to reduce tar yields steeply because of consumer resistance, and because "smokers would be liable to `compensate' for reduced tar and nicotine yields by smoking each cigarette more intensively and/or by smoking more cigarettes".[58] However, the ISCSH observed that even if a smoker did increasingly compensate so that his or her smoke uptake did not decline greatly from year to year, "it is unlikely that many smokers would now seek doses of any smoke component as high as those of 20 years ago"[59]

ADDITIVES

  4.59  Additives can be defined as those substances, other than water, which are added to tobacco products in the course of manufacture and which are intended to be burnt when products are smoked.

  4.60  Prior to 1970, the use of additives in tobacco products had been the subject of long standing restrictions, as a consequence of fiscal legislation, which required HM Customs & Excise to approve the use of any additive in a tobacco product. The 1970 Finance Act relaxed the restrictions on the use of additives, although approval for their use was still required from HM Customs & Excise.

  4.61  During the early 1970s there was dialogue between HM Customs & Excise, the then Department of Health and Social Security and the UK tobacco companies concerning the establishment of directions for the use of additives. Following the establishment of the ISCSH in 1973 that Committee was mandated to prepare guidelines for the testing of additives. In line with recommendations contained in the First Report of the ISCSH, in 1975, the Department of Health and Social Security began maintaining a list of approved additives (now called the "permitted list") which tobacco companies were allowed to use in cigarette, cigar, pipe and hand-rolling tobaccos. The list also specified the maximum usage for all additives and aggregate usagelimits in respect of each additive contained on the list. Given the historical nature of the list and theevolution of tobacco products prior to 1975, at present, the permitted list contains approximately 600 different additives.

  4.62  Currently, underpinning the use of additives in the UK is the 1997 voluntary agreement which superseded previous voluntary agreements and was entered into between the members of the TMA, the members of the Imported Tobacco Products Advisory Council and the Department of Health. That agreement also regulates the use of additives contained on the permitted list, and sets out the steps which have to be undertaken before any new ingredient can be added to the permitted list. Under this agreement Gallaher was also required to identify tobacco processing agents used in manufacture and the adhesive used to join cigarette papers and cigar seams.

  4.63  Accordingly, the use of all additives in tobacco products in the UK has been strictly regulated over the years and the level of regulation has increased since the restrictions on the use of additives were relaxed in 1970. A copy of the current permitted list of additives, which is dated September 1998, can be obtained from the Department of Health, upon request.

  4.64  All additives that are used in Gallaher's products comply with the UK list of permitted additives. To ensure adherence, since the implementation of the 1997 voluntary agreement, Gallaher certifies its compliance to the Department of Health annually. The additives used by Gallaher also comply with all national regulations and agreements in the countries in which Gallaher's products are sold.

  4.65  Traditionally, additives have been used in the course of manufacture of tobacco products to improve product quality. Additives are essentially used by Gallaher both for technological purposes and to give individual products their distinctive flavour and aroma characteristics. Such additives are mainly used by Gallaher in pipe and hand-rolling tobaccos. In cigarettes, only two brands manufactured by Gallaher, with very small market shares, contain flavourings.

  4.66  Excluding the menthol cigarettes manufactured by Gallaher and the two brands containing flavourings, in total Gallaher only uses six additives in the cigarette brands that it manufactures for sale in the UK. The overall collective amount of these additives, by weight, is between 3 per cent and 4 per cent of the tobacco rod, depending upon the particular brand of cigarette. The details of these additives, with a description of their uses, are set out below:

(a)  Adhesive—used to seal the side seams of cigarette papers. The adhesive is water based and is solvent free.

NICOTINE AND ADDICTION

  4.70  Nicotine occurs naturally in tobacco leaf and its levels will vary with climatic changes from year to year. Gallaher purchases and blends tobaccos for taste, flavour and quality. The factors affecting the nicotine yields (and, indeed, the tar yields) of cigarettes, when smoked, include the overall weight of tobacco, the types of tobacco and tobacco sheet (if any) that are used and the constitution of the blend of tobacco present in the rod. The nicotine yield will also be affected by the density of the tobacco rod and the cigarette papers, filters and ventilation techniques that make up any particular brand of cigarettes.

  4.71  Gallaher does not artificially increase the nicotine contents in its cigarettes. Indeed, the manufacturing process used by Gallaher actually reduces the overall nicotine contents of blends relative to unprocessed tobacco. The levels of the nicotine yields of the cigarette brands manufactured by Gallaher, which are measured according to ISO standards, do, of course, vary. The numbers for each brand are printed on the cigarette packets themselves. As the tar yields of cigarettes have reduced over the years, so have the nicotine yields. For example, in 1979-1980 the tar and nicotine numbers for Benson & Hedges Special Filter were 18mg and 1.6mg respectively. Currently, the tar and nicotine numbers for that brand are 11mg and 0.9mg respectively.

  4.72  The issue of addiction, which is associated with nicotine, has been identified as complex for many years and remains so. Some have suggested that people smoke cigarettes solely to obtain nicotine. Gallaher believes that view is too simplistic. If that were so, every cigarette smoker who uses nicotine chewing gums, inhalers or patches would stop smoking.

  4.73  Central to the issue is a concern that cigarette smoking is addictive and that this removes the choice of smokers as to whether to give up or continue smoking. As appendix 2 illustrates,[60] from the 1950s cigarettes have been portrayed as addictive in the popular press and media. Yet, millions of people have stopped smoking. For instance, taking the figures of 1996, of the persons living in the UK aged 16 or over who had at one time or another smoked cigarettes regularly, 30 per cent of men and 21 per cent of women, equivalent to between 11 and 12 million people, had stopped smoking.[61]

  4.74  Over the years there has been considerable disagreement between scientists and medical bodies in their attempts to arrive at a single satisfactory definition of the word addiction. Furthermore, the meaning attributed by various public health authorities to the term addiction has changed over the years. For instance, the US Surgeon General's Report of 1964,[62] referring to tobacco, commented as follows:

"The tobacco habit should be characterised as an habituation rather than an addiction, in conformity with accepted World Health Organisation definitions, since once established there is little tendency to increase the dose; psychic but not physical dependence is developed; and the detrimental effects are primarily on the individual rather than society. No characteristic abstinence syndrome is developed upon withdrawal."

  4.75  By 1988, however, the definition of addiction used by the US Surgeon General had varied so that it included tobacco:[63]

"Cigarettes and other forms for tobacco are addicting. Nicotine is the drug in tobacco that causes addiction. The pharmacologic and behavioural processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine."

  4.76  The varying use of the term addiction is also illustrated by the differing usages applied to it by the World Health Organisation ("WHO"). In the late 1950s and 1960s, WHO defined addiction in such a way that this definition would be inapplicable to smoking:[64]

"Reviewing at this time the definitions of addiction-producing and habit forming drugs in its second report and clarified in its third report, the Committee was of the opinion that the time was ripe for emphasising again the distinction between addiction and habituation (see Annex, page 12). To this end the following definitions were approved:

Drug addiction

Drug addiction is a state of periodic or chronic intoxication produced by the repeated consumption of a drug (natural or synthetic). Its characteristics include:

(1)  an overpowering desire or need (compulsion) to continue taking the drug and to obtain it by any means;

(2)  a tendency to increase the dose;

(3)  a psychic (psychological) and generally a physical dependence on the effects of the drug;

(4)  detrimental effect on the individual and on society.

Drug habituation

Drug habituation (habit) is a condition resulting from the repeated consumption of a drug. Its characteristics include:

(1)  a desire (but not a compulsion) to continue taking the drug for the sense of improved well-being which it engenders;

(2)  little or no tendency to increase the dose;

(3)  some degree of psychic dependence on the effect of the drug, but absence of physical dependence and hence an abstinence syndrome;

(4)  detrimental effects, if any, primarily on the individual."

  4.77  In this definition, the characteristics of addiction used by WHO include an overpowering desire or need (compulsion) to continue taking the drug and a tendency to increase the dose; whereas, by contrast, the characteristics of habit include a desire (but not a compulsion) to continue taking the drug and little or no tendency to increase the dose. In the context of this definition, clearly cigarette consumption falls within the meaning of habit. Whilst WHO did not apply the term addiction to smoking in 1964,[65] today, WHO employs a changed definition of addiction which does include smoking.[66]

  4.78  In Gallaher's opinion the meaning of addiction has been given such a wide interpretation in today's society that it can encompass almost any type of behaviour, including smoking. That is the nature of the changing definitions of addiction.

  4.79  Gallaher's view is clear. Smoking is a habit, and with the frequent repeated rituals of lighting up and taking puffs, for some it can be a very strong habit. The key question, however, is whether or not people can give up smoking. Some may well find it harder than others, but millions of people have given up smoking in the UK and elsewhere.

  4.80  So, no matter how smoking is termed—addiction or habit—smokers can and do quit. People give up smoking at different times in their lives with different motivations. People can choose to smoke; they can choose to stop, even if some people find it much more difficult than others to do so.

GALLAHER'S APPROACH TO SMOKING AND HEALTH

  4.81  Since the smoking and health debate developed in the UK in the 1950s, Gallaher has looked at and continues to look at new research ideas, new materials and ways of improving its brands. In line with Government thinking, Gallaher has been at the forefront of the steps that have been taken to lower the tar yields of its brands of cigarettes. Indeed, as the history of Silk Cut shows, Gallaher's research activities have been applied to attempt to reduce the risks associated with cigarette smoking by product modifications. As can be seen by the profile printing example,[67] not everything looked at goes into production, or results in a product that is sold to Gallaher's customers. By its very nature, much research and development is speculative and does not necessarily lead either to acceptable or viable product applications. There is nothing unique to Gallaher or tobacco about this; any company manufacturing consumer products goes through the same research and development processes, where many novel ideas are rejected, after consideration, and even those that appear feasible are not acceptable to consumers.

  4.82  Gallaher continues to monitor the research undertaken in the field of smoking and health. Currently, in line with its focus upon overall tar yield reduction, Gallaher's research initiatives are centred upon development activities, with a particular concentration upon product and process monitoring and development. Gallaher also continues to explore various product innovations based on its own thoughts and ideas, papers published by researchers and scientists and dialogue with regulatory authorities.

  4.83  For many years, Gallaher has proceeded on the assumption that cigarette smokers are more likely to contract lung cancer and certain other diseases than non-smokers. Accordingly, Gallaher has co-operated with Government in seeking ways to reduce the risks associated with smoking. In particular, Gallaher has positively and voluntarily taken steps to try to reduce the risks associated with smoking. Some studies have suggested that smokers of lower tar cigarettes have a reduced risk of lung cancer, other recent studies suggest otherwise. The statistics have not however demonstrated that there is a risk-free level of smoking, nor that any smoker will avoid an associated disease by smoking less. Indeed, it is Gallaher's position that it remains impossible to predict whether and if so, how, and to what extent, reducing tar yields of cigarettes has health consequences for an individual cigarette smoker. To date, however, no better course than tar reduction has been advocated by public health authorities to meet the health concerns surrounding those who choose to smoke.

  4.84  So far as the overall issue of the scientific knowledge associated with the harmful effects of smoking is concerned, Gallaher recognises that starting with the publication of the Doll and Hill reports in the 1950s, the quantity and quality of the statistical evidence reporting the association between cigarette smoking and lung cancer have increased. In the view of Gallaher, the strength of the statistical evidence is sufficient to conclude that it is substantially more probable than not that cigarette smoking can and does cause lung cancer in some smokers. Indeed, in the smoking and health litigation before the English court, the December 1998 hearing to determine whether or not certain of the claimants could continue with their claims, proceeded on the assumption that smoking can cause lung cancer. The statistics cannot, however, predict what will happen to any individual and despite the extensive research that has been undertaken, since the 1950s, science has yet to determine which smokers will contract lung cancer and which will not. Furthermore, despite the decades of scientific research, the biological mechanism by which lung cancer is caused and the role that cigarette smoking plays remain unknown.[68]

  4.85  Gallaher also recognises that the statistical evidence shows that cigarette smoking is a risk factor for a number of other diseases, such as chronic bronchitis, heart disease and certain other vascular diseases.

  4.86  Given this position, Gallaher is open to all constructive ideas for the further modification of cigarettes that might assist in the reduction of the risks associated with smoking. Gallaher cannot, however, act in isolation and believes that any course that is adopted should be achieved with the support of regulators and with the promotion and backing of Government. In particular, there is a willingness on Gallaher's part to explore with Government the issues that have recently been raised concerning possible new approaches to the measurement of the constituents of cigarette smoke and the further information that can be provided to the smoker.[69]

  4.87  Gallaher would like to see the level of co-operation with the Department of Health, and other bodies advising Government, enhanced and a position achieved whereby Gallaher can openly consult with regulators and ask for advice and/or assistance or, at least, comment on proposed measures. Furthermore, if the proposed "advertising ban" becomes law on 10 December 1999, the only way that Gallaher will, in future, be able to communicate with its consumers will be through Government or with its express approval. To exemplify the point, Gallaher will not be able to inform consumers of proposed product modifications or communicate with them to ascertain whether such product modifications are acceptable to them or what actions need to be undertaken by Gallaher to ensure the acceptability of such modifications to consumers. As a consequence, the importance of the role played by the Government in backing, supporting and promoting future approaches to reduce further the risks associated with smoking will increase.

47   International Standards Organisation ("ISO") recognised methodology which is in use across most of Europe (ISO4387:1991). The method is also embodied in BS5202 Part 14. Back

48   See appendix 1, paragraphs 7.9 to 7.10. Back

49   European Council Directive 89/662/EEC and The Tobacco Products Labelling (Safety) Regulations 1991. Back

50   "Tar and Nicotine Yields of Cigarettes", Health Departments of Great Britain, April 1973. Back

51   Appendix 3 to the Fourth Report of the ISCSH, 1988. Back

52   See, for instance, "Nicotine and the Self-Regulation of Smoke Intake", MAH Russell, published in Nicotine, Smoking, and the Low Tar Programme, edited by Wald and Froggatt, Oxford University Press, 1989. Back

53   "Relationship of Number of Cigarettes Smoked to "Tar" Rating", S Waingrow and D Horn, National Cancer Institute Monograph no28, 1968; "Puffing Frequency and Nicotine Intake in Cigarette Smokers", H Ashton and D Watson, British Medical Journal, 1970, 3, 679. Back

54   "Smoking and Health Now", report by RCP, 1971, p 133. Back

55   "Smoking or Health", report by RCP, 1977 p122; "Health or Smoking?", report by RCP, 1983, p 84. Back

56   Third Report of the ISCSH, 1983. Back

57   Fourth Report of the ISCSH, 1988, pp 8-10. Back

58   Fourth Report of the ISCSH, 1988, p 2, paragraph 6. Back

59   Fourth Report of the ISCSH, 1988, p 10, paragraph 28. Back

60   See appendix 2, paragraphs 8.29 to 8.33. Back

61   "Alcohol consumption and smoking", Health Survey for England 1996, B Hedges and P di Salvo, table 8.8. Back

62   "Smoking and Health", US Surgeon General, 1964, p 354. Back

63   "The health consequences of smoking-Nicotine Addiction", US Surgeon General, 1988, p 9. Back

64   "WHO Expert Committee on Addiction-Producing Drugs. Seventh Report", Technical Report Series No.116, 1957, referred to in the Report of the US Surgeon General, 1964, p 351. Back

65   "WHO Expert Committee on Addiction Producing Drugs. Thirteenth Report", Technical Report Series No 272, 1964. Back

66   "ICD-10 International Statistical Classification of Diseases and Related Health Problems", 10th Revision, Vol 1, World Health Organisation, 1994. Back

67   See paragraphs 4.43 to 4.45. Back

68   "The Tobacco Products Research Trust 1982-1996", Swann and Froggatt, 1996, Royal Society of Medicine Press, p 4. Back

69   "The future of tobacco product regulation and labelling in Europe: implications for the forthcoming European Union directive"; Tobacco Control 1999; 8, pp 225-235, Clive Bates (Action on Smoking and Health), Ann McNeill (Health Education Authority), Martin Jarvis (Imperial Cancer Research Fund) and Nigel Gray (European Institute of Oncology, Milan). Back