THE TOBACCO INDUSTRY AND THE HEALTH RISKS OF SMOKING
http://www.parliament.the-stationery-office.co.uk/pa/cm199900/cmselect/cmhealth/27/2709.htm#n54

Nicotine addiction

28. The Royal College of Physicians 1962 and 1971 reports on smoking recognized that smokers might be addicted to nicotine.[54] In Britain more specific research which traced the effects of nicotine was, according to the RCP, conducted at two locations. One was the Institute of Psychiatry, where the development of the blood nicotine assay "helped to establish the role of nicotine as the major controlling factor in smokers' regulation of smoke intake".[55] The second location where such research was being conducted was within the tobacco industry itself. According to the RCP the industry was "establishing a sophisticated understanding of the role of nicotine in smoking behavior".[56]

29. It has taken some time for the implications of the role of nicotine addiction in smoking to be reflected in public health policies. The 1980s saw a number of studies analyzing nicotine addictiveness using animal self-administration studies, as well as neurochemical studies, and analyses of absorption and dependence and craving and withdrawal. A major influence on the climate of policy was the publication in 1988 of the US Surgeon General's Report, The health consequences of smoking, nicotine addiction. The analysis that nicotine addiction underlay smoking behaviour led to the US Food and Drug Administration attempting in 1996 to assert jurisdiction over tobacco products.

30. Normally the FDA regulated drugs which manufacturers wanted to put on the market, that is to say manufacturers themselves sought regulation. The cigarette companies, however, strenuously resisted regulation and mounted a legal challenge to the FDA. Provision existed in statute to allow the FDA to take into account the intent of the manufacturer (so that the FDA merely needed to prove that the cigarette companies intended to deliver a "pharmacologic effect" for it to claim jurisdiction over tobacco products).[57] The FDA felt that this evidence was not clear in 1994 so they mounted a lengthy investigation into the use of nicotine in tobacco products. Following this investigation the FDA concluded that cigarettes "were delivery devices for the drug nicotine".[58]

31. During their investigations the FDA learnt precisely how the US cigarette companies had blended tobacco products. One company's handbook on leaf blending was anonymously submitted and from that the agency "learned that tobacco companies used chemical additives to affect the delivery of nicotine".[59] The actual blending allowed the companies to achieve fine tuning over the levels of the nicotine delivered. The former director of applied research at Philip Morris told the agency that "product developers and blend and leaf specialists at Philip Morris were responsible for manipulating and controlling the design and production of cigarettes in order to satisfy the customer's need for nicotine".[60]

32. The Supreme Court rejected the FDA's case on 21 March 2000. It determined that the statute setting up the FDA, the Food Drugs and Cosmetic Act, excluded tobacco which Congress had sought to control by means of other measures.[61]

33. We believe that the publication of the recent RCP report Nicotine Addiction in Britain should have as much impact on the public health debate on smoking as the seminal studies relating to lung cancer and heart disease of the 1950s and early 1960s. The RCP reviewed an enormous amount of material. For example, they analysed whether nicotine use through smoking met standard diagnostic criteria for addiction, a point we pursued with the companies. They listed the two most widely recognized diagnostic criteria for substance dependence - the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria and the World Health Organization International Classification of Diseases ICD-10 criteria:

Summary of Diagnostic and Statistical Manual of Mental Disorders, DSM-IV and International Classification of Diseases ICD-10 criteria for substance dependence.[62]

The RCP concluded that smoking particularly met the criteria for "difficulty in controlling use" "continued use despite harmful consequences" "tolerance" and "withdrawal".[63] Overall, the RCP drew the following main conclusion:

"Cigarette smoking should be understood as a manifestation of nicotine addiction ... the extent to which smokers are addicted to nicotine is comparable with addiction to 'hard' drugs such as heroin and cocaine."[64]

We endorse this conclusion, which underlies many of the recommendations in our report and is, we believe, of fundamental importance to policy makers in the UK and elsewhere.

The response of the tobacco companies to evidence of the health risks of smoking

34. Evidence from internal company memoranda, many of which have come to light as a result of the Minnesota litigation, suggests that tobacco companies have been aware of the dangers of smoking for decades. Mr Martyn Day, a solicitor in the firm of Leigh, Day and Co., which represented hundreds of claimants in unsuccessful actions against the tobacco companies between 1992-98 and had access to "hundreds of thousands of pages"[65] of internal tobacco company documents under the discovery process, suggested "in 1958 Dr Bentley, a leading research scientist for Imperial, accompanied two other British tobacco experts on a trip to meet a number of scientists from the US tobacco industry and other independent experts. In their report of the meeting to Imperial they said: 'with one exception ... the individuals whom we met believed that smoking causes lung cancer'."[66] The joint memorandum from ASH and the RCN quoted a number of other examples:

- "the sum total of scientific evidence establishes beyond reasonable doubt that cigarette smoke is a causal factor in the rapidly increasing incidence of human epidermoid cancer of the lung....[this is] a view with which we concur" (Paul Kotin, a pathologist at the Tobacco Industry Research Committee, 1957).[67]

- "the results of the research would appear to us to remove the controversy regarding the causation of the majority of human lung cancer.... to sum up we are of the opinion that the Auerbach work proves beyond reasonable doubt the causation of lung cancer by smoke." (The Research Manager, Gallaher, 1970. In 1998, Gallaher stated that this memorandum was an initial reaction and that its views were later discounted.).[68]

Reviewing the Minnesota evidence, the World Health Organization concluded that for decades tobacco companies, including those in the UK, have "denied or minimized the overwhelming scientific evidence of the dangerous effects of tobacco".[69]

35. Little of the evidence we received from the tobacco companies dwelt on the public statements they had made in the past as to the health risks of smoking. Mr Martyn Day's memorandum, however, listed a number of public pronouncements on this subject made by senior representatives of tobacco companies since the 1950s:

-  "The Tobacco Manufacturers Standing Committee stated yesterday, after considering the statements by the Minister of Health and the Medical Research Council, that it had not been established with any certainty and to what extent there might be a causal connection between smoking and cancer of the lung." (The Times, 28 June 1957)[70]


- Dr Wakeham, Vice-President of Philip Morris said:


"You must be trying to get me to admit that smoking is harmful. Anything can be considered harmful. Apple sauce is harmful if you get too much of it.


Q I don't think many people are dying from apple sauce.


Dr Wakeham: They're not eating that much. I think that if the company as a whole believed cigarettes were really harmful, we would be out of business. We're a very moralistic company." ("Death in the West", Thames TV, 1976)[71]


- "letter by Richard Duncan from BAT subsidiary saying "The company does not believe that cigarette smoking is harmful to health." (The Sunday Times, 3 May 1990).[72]

36. We sought to establish as accurately as we could the position of the major companies operating in the UK on the dangers of active and passive smoking and on the degree and nature of nicotine's addictiveness as delivered via cigarettes. The companies' stance was generally to 'recognize' the evidence, without tending to comment on it. For example, "Gallaher recognises that starting... in the 1950s, the quantity and quality of the statistical evidence reporting the association between cigarette smoking and lung cancer have increased. For many years, Gallaher has proceeded on the assumption that cigarette smokers are more likely to contract lung cancer and other diseases such as chronic bronchitis, heart disease and other vascular diseases than non-smokers".[73] In oral evidence, Mr Peter Wilson, Executive Chairman of Gallaher, said "we understand and accept that there is a general agreement amongst most people today, particularly the medical and scientific community, that smoking can be dangerous and can cause a number of diseases. I am not going to begin to argue with that ...".[74] Similarly Philip Morris in its memorandum said that it " recognizes, for example, that epidemiological studies have concluded that the incidence of lung cancer among smokers is many times greater than among non-smokers".[75]

37. Following the oral evidence session we submitted a number of detailed written questions to the companies to establish for the record their current public position on the health risks of smoking and the addictiveness of nicotine. The responses of the companies are summarized in the table below:

38. The responses to our questions accurately reflected the positions taken during the evidence session. Gallaher, Philip Morris, BAT and R J Reynolds all either directly acknowledged that smoking caused serious diseases, or acknowledged that there was a consensus amongst public health bodies that this was the case.[77] In stark contrast, Mr Gareth Davis of Imperial refused to accept directly any of the evidence, nor did he appear to think it was his role to evaluate this evidence. He told us: "I do not think that we can say that it [smoking] is safe or unsafe ... we do not know whether it is safe or unsafe".[78] He added that "we do not agree that smoking has been shown to be a cause [of certain diseases]".[79] We discuss below our response to Imperial's position.

39. In its memorandum Imperial told us that, together with the Tobacco Manufacturers Study Committee / Tobacco Research Council, it "consulted and took advice from leading scientists on the direction of research carried out and the interpretation of the results of the research".[80] A list of distinguished scientists was supplied: Sir Charles Dodds, President of the RCP Committee of Air Pollution, Sir Ronald Fisher, Professor of Genetics at Cambridge University, Sir John Richardson, President of the Royal Society of Medicine, Lord Todd, Professor of Organic Chemistry at Cambridge University, Professors Sir Alexander Haddow, R D Passey and E Boyland of the Chester Beatty Institute of Cancer Research at the Royal Cancer Hospital London, Professors Sir Ernest Kennaway and J W S Blacklock of St Bartholomew's Hospital, Dr C M Fletcher, co-author of the 1962 RCP report on Smoking and Health, and Dr J W Cook of the MRC Carcinogenic Substances Research Unit, University of Exeter.

40. We asked Imperial to supply us with the written interchanges between the company and these scientists.[81] We felt that the implication of Imperial drawing our attention to the advice they received from eminent medical authorities was that this advice had governed their conduct in assessing the health risks of smoking. The resulting dossier they submitted was extremely unconvincing. In the case of several scientists there was either no correspondence at all (Sir Ronald Fisher; Lord Todd; Sir Ernest Kennaway; J W Blacklock) or nothing which touched on matters of substance ((Dr W Carruthers and Dr J W Cook). From Sir Charles Dodd there were a mere three pages covering the period 1952-72. The bulk of the material comprised exchanges between Charles Fletcher and Geoffrey Todd of the Tobacco Research Council and related to research the TRC was funding in Professor Fletcher's laboratory. There is nothing here to suggest that Imperial was seriously seeking his views and advice; instead the correspondence generally deals merely with the administration of grants for research. In many cases the evidence is incomplete with only one side of the correspondence surviving. There are occasional indications that, if more of the correspondence survived, more would be known of the companies' actual understanding of the health risks of smoking. For example, Charles Fletcher describes a discussion with Geoffrey Todd thus: "The evidence you told me about certainly suggests that nicotine is the basis of cigarette addiction". In 1964 E Boyland suggested "greater efforts should be made to detect ... nitrosamines in cigarette smoke". Yet only recently have processes to remove nitrosamines been developed. Overall, however, the package of materials supplied is patchy and fails to give documentary support to the idea that these scientists were a source of valued advice on matters relating to the company's stance on smoking and health. Some of the deficiencies may be attributable to the passage of time, but the general lack of material in which Imperial either seeks or receives advice suggests that this may never have been a high priority.

41. We also sought the views of the five companies on the health risks of environmental tobacco smoke. Mr Wilson of Gallaher rejected the findings of SCOTH that, amongst other things, ETS caused lung cancer and heart disease.[82] In written evidence BAT told us that they believed that "the claim that ETS presents a health hazard is not supported by the science".[83] They argued that most studies of ETS have not shown any statistically significant increase in risk. In respect of dangers to children they noted "a number of reports of statistically significant increased risk of respiratory disorders in pre-school children exposed to ETS".[84] Here they contended that the increased risks may be due to other factors statistically more common in households with smokers such as diet and housing conditions. They went on to suggest that the pattern of increased risk is "not consistently replicated" in children of school age indicating that any real effects are short-lived. They concluded "it is right that parents and other adults be particularly sensitive to the needs of young children, especially infants, for a clean, comfortable environment. It makes sense not to smoke around infants, especially in poorly ventilated environments and not to smoke around young children for long periods".[85]

42. We found BAT's analysis of the epidemiology of environmental tobacco smoke largely unpersuasive. If they believe that no increased risk arises from passive smoking it is unclear why they thought it "makes sense" not to smoke around children for long periods. The word they - and Mr Wilson of Gallaher and Simon Clark of FOREST - used to describe the effect of ETS on non-smokers was "annoying".[86] We asked Mr Wilson whether he would define an asthmatic attack, which the SCOTH report considered could be triggered by ETS, as merely "annoying".[87] He replied that he accepted that ETS was "annoying, can cause this kind of unpleasantness but not lung cancer, heart disease etc." Bearing in mind that asthma causes 1,400 death per year,[88] we do not regard asthma attacks as merely unpleasant and believe that policy goals related to ETS must take account of the real health risks it poses.

43. We also questioned Mr David Davies of Philip Morris about the activities of his company in respect of the debate on ETS. We specifically asked him to explain the function of Operation Whitecoat and to indicate the role of the late Professor Roger Perry of Imperial College in his capacity as an advisor to the Environment Committee on its 1991 inquiry into indoor air quality, which included a substantial section on environmental tobacco smoke. Mr David Davies told us that Operation Whitecoat was "the name given to activities in which we engaged in the late eighties and early nineties which were designed to solicit the support of those who shared our views in relation to environmental tobacco smoke and indoor air quality". Mr Davies revealed that Professor Perry was associated with the tobacco industry from the late 1980s and "subsequently became affiliated directly with Philip Morris". Mr Davies assured us that Professor Perry's affiliation with the industry and with Philip Morris was "very well known".[89]

44. We wrote to Mr David Davies requesting further evidence that Professor Perry's contract with Philip Morris had been notified to the Environment Committee. In response they submitted a newspaper cutting from 1988 which noted that Professor Perry had conducted research on indoor air quality funded initially by the Tobacco Advisory Council and later by Philip Morris and a New Scientist article which, based on documents released as a result of the Minnesota litigation, suggested that Philip Morris "secretly recruited influential people to help allay fears about the health risks from passive smoking". This article also cited the former Clerk to the Environment Committee as acknowledging that the Committee members "knew Perry had done research for the tobacco industry"; according to the article, the Clerk went on to add "he cannot recall Perry mentioning that he had any deeper relationship with Philip Morris".[90] We went back to the then Clerk of the Environment Committee who confirmed that, as far as he was aware, the Committee had known that Professor Perry had conducted research in the past for the tobacco industry but had not been told of his other contracts with Philip Morris, although he acknowledged that Professor Perry "may have mentioned the fact that he had a general retainer from Philip Morris to the then Chairman, Sir Hugh Rossi MP".[91]

45. The issue of ETS is crucially important for the tobacco companies. The central strand of their defence of their activities is that smoking is a matter of free and informed adult choice. If dangers are found to attach to other people's smoke, and if non-smokers such as young children in a smoker's house are unable to avoid that smoke, those non-smokers are not exercising free choice at all. The extent of nicotine's addictiveness is similarly crucial. Mr Martyn Day told us that, in law, "if you get an individual case ... there is a big debate about whether someone voluntarily accepts the risk that they are pursuing - it is a legal argument called volente - part of the legal case would be that you cannot voluntarily accept a risk if you are addicted to the substance you have been using".[92] Similarly, ASH/RCN noted: "To recognize publicly the evidence for pharmacological nicotine addiction would ... undermine the assertion that smokers choose to do so as a matter of 'free will'. Without the 'free will' argument, a key part of the industry's defences in product liability litigation would be destroyed".[93] They draw attention to the startling image of seven Chief Executive Officers of US tobacco companies each testifying on oath during the 1994 US Congressional Hearings before the sub-committee on Health and the Environment of the Committee on Energy and Commerce that, in their view, nicotine was not addictive.[94]

46. In evidence in July 1999 before the Irish Joint Committee on Health and Children, Mr Ian Birks, Head of Corporate Affairs at Gallaher, told members:

"The confusion in the debate is when we get to the use of the word addiction because it is an emotive word. It is a word which tends to get used in many different ways. A couple of weeks ago I was driving to work and I heard on the radio that 10 million Americans are addicted to the internet. We know of people who are addicted to soap operas, tea, coffee, cream cakes, chips etc. The difficulty is that when the word is used broadly to describe all kinds of behavioural habits, then clearly smoking is a habit. It can be a strong habit for some people, but we reject the fact that people are addicted to smoking and cannot stop smoking because they can and do."[95]

47. In written evidence Gallaher drew attention to the fact that, whereas the US Surgeon General's report of 1964 characterised smoking as "an habituation rather than an addiction", in 1988 he concluded that cigarettes and other forms of tobacco were addicting.[96] The conclusion that Gallaher came to was that "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".[97] Mr Broughton of BAT similarly referred to the two definitions produced by the US Surgeon General. He contended that efforts by manufacturers to alter the nicotine:tar ratio so that smokers got more nicotine with reduced tar had not satisfied their consumers.[98] Nicotine he described as having a "mild" pharmacological effect "on a par with caffeine".[99] In its written memorandum BAT argued that "people say they are addicted to particular foods, using the internet, taking exercise, watching certain television programmes, or even to working".[100]

48. We asked Mr Broughton to expand on why his company had included such comparisons. He told us that "What the memorandum is trying to do is to say that we can get bogged down in semantics. There is a real danger that the current popular definition of addiction can be used for all sorts of things and not differentiate sufficiently between them. It does cover things like the internet. I think it is quite wrong to cover that ...".[101] But in his opening remarks to us, Mr Broughton demonstrated exactly why precision is essential in discriminating between habits and pharmacological addiction: "Let us just accept for the sake of moving forward that the popular understanding today is that smoking is addictive. Nevertheless our customers are not fools nor helpless addicts ...".[102] In our view, Mr Broughton's statement here shows just how dangerous and misleading the semantic vagueness which he purportedly decries can be: having indicated his unhappiness with the vagueness of the term "addiction" he then glibly exploits it. His confident assertion that his customers are not "helpless addicts" only makes sense if the addictiveness of smoking "in the popular understanding," which he apparently accepts, excludes pharmacological dependence.

55   ibid., p.90. Back

56   ibid., p.91. Back

57   David A Kessler et al., "The Food and Drug Administration's Regulation of Tobacco Products", The New England Journal of Medicine, 1996:335, p.988. Back

58   ibid., p.991. Back

59   ibid., p.990. Back

60   ibid., p.990. Back

61   The Times, 22.3.00. The text of the judgment can be found at www.cornell.edu/supct. Back

62   Nicotine Addiction in Britain, p.85. Back

63   Nicotine Addiction in Britain, pp.86-87. Back

64   Nicotine Addiction in Britain, p.183. Back

65   Ev., p.80. Back

66   Ev., p.90. Back

67   Ev., p.61. Back

68   Ev., pp.61-62. Back

69   Ev., p.97. Back

70   Ev., p.89. Back

71   Ev., p.90. Back

72   Ev., p.90. Back

73   Ev., p.170. Back

74   Q391. Back

75   Ev., p.228. Back

76   Information in the tables is sourced from Ev., pp.340-41, 356-57, 358, 359, 360. Back

77   See QQ388-435 and QQ462-69 passim. Back

78   QQ397-98. Back

79   Q418. Back

80   Ev., p.207. Back

81   TB13F (not published). Back

82   Q581. Back

83   Ev., p.159. Back

84   Ev., p.160. Back

85   Ev., p.160. Back

86   Ev., p.159; Q614. Back

87   Report of the Scientific Committee on Tobacco and Health, 1998, pp.31-32. Back

88   ONS Mortality Statistics 1998. Figures are for England and Wales.  Back

89   Q1067. Back

90   New Scientist, 16.5.98, p.4 (cited Ev., p.634). Back

91   Ev., p.630. Back

92   Q1198. Back

93   Ev., p.62. Back

94   Ev., p.62. Back

95   The Houses of the Oireachtas Joint Committee on Health and Children, Minutes of Evidence relating to Smoking and Health, November 1999, p.35. Back

96   Ev., p.184. Back

97   Ev., p.184. Back

98   Q550. Back

99   Q573. In its written evidence BAT described the pharmacological effects of nicotine as "milder than ... coffee". See Ev., p.153. Back

100   Ev., p.153. Back

101   Q575. Back

102   Q388. Back