THURSDAY 18 NOVEMBER 1999

PROFESSOR LIAM DONALDSON, DR DAWN MILNER, MR TIM BAXTER AND MR PAUL LINCOLN

  100. The Consumer Protection Act has not been part of your submission and it would be quite useful to know what legislation there might have been available to look at the products that are being foisted on the public.
  (Mr Baxter) We can certainly return to that.
  (Professor Donaldson) We will submit a separate memorandum on that, Chairman.

  101. This discrepancy between the control of NRT and controlled tobacco does seem quite bizarre as far as I am concerned.
  (Mr Baxter) Coming back to the proposal for a nicotine regulatory authority, we have not given this very detailed considered thought and your Committee may propose that and in the meantime we will give it more thought. If you drafted it onto the Medicines Control Agency's existing powers I think they would find it difficult. That does not mean it cannot be done, but I think creating that new wider agency is not a trivial task. In America there is experience with the food and drug administration which has claimed the right to regulate tobacco products and you are probably aware that that issue is being fought right up the courts. I cannot speak for what the industry would do in response to such a proposal, but I think it is fair to say that it would not be an easy bit of legislation.

  102. I am not really that interested in what the industry thinks about that. I am more interested in what we want to achieve. Clearly the current policy is not achieving what we want to see which is young people not starting to smoke.
  (Mr Baxter) I personally—and I may be quite wrong in this—do not think there is enough knowledge about nicotine and the way we want the policy on nicotine to go to justify setting up a regulatory authority which would know what to do. I think the priority should be better knowledge and scientific research into nicotine. That is my very much provisional response to this suggestion and we will think about it further.

  Dr Brand: It is not our suggestion. The memorandum from the Imperial Cancer Research Fund talks about this. I am sure it will come across your desk.

  103. I think we have to be very careful that we do not call everything "nicotine". We are talking about tobacco and tobacco is a dangerous product. Clearly we have to have some mechanism for controlling its use. It has to come into some statutory regulations. If, for example, a car manufacturer produced a car that we knew killed 50 per cent of people who drove it regularly I do not think people would buy it and if our trains killed 50 per cent of regular commuters to London I think we would have difficulty. The fact that we have got a product that does kill 50 per cent of those that use it regularly and there does not seem to be any statutory framework for its proper control—
  (Mr Baxter) There is a statutory framework under the Consumer Protection Act.

  Dr Stoate: Dr Brand has made a very important point. It does not seem to be classified as a drug, it does not seem to be classified as a food, it does not seem to be classified as an ordinary product for consumer protection, it does not seem to come under health and safety regulation. It seems to have managed to have got through the net extremely effectively over the years and I think it is fair to ask why and what we are going to do about it.

  104. I want to ask about the content of tobacco itself. What research has the Department done on the extent to which the different constituents of tobacco are themselves carcinogenic?
  (Dr Milner) I can only answer by way of recent research that I am aware of, but I could find out more for you and get back to you about this one. I know the laboratory of the Government Chemist has looked at measurements of benzene in cigarettes and nitrous oxide and there is one other study which escapes my mind at the moment. There has been some recent research that the Department of Health has funded into looking at particular components of tobacco smoke. Before that, of course, there were 37 research studies carried out under the auspices of the Tobacco Products Research Trust, which again I do not have at my fingertips, but I could easily list those that were relevant to the question that you have asked about the constituents of tobacco.

  105. Are nitrosamines carcinogenic?
  (Dr Milner) I believe it is correct to say that nitrosamines are carcinogenic.

  106. Are companies allowed to market tobacco products with large levels of nitrosamines in them or has that analysis not been carried out?
  (Dr Milner) It is not something that the Government regularly measures for. I have been made aware that it is now possible to remove nitrosamines from tobacco and I have heard that a tobacco company in America, the Star Tobacco Company, has developed a technique whereby nitrosamines can be removed and would happily label their product, "Nitrosamines, 0.00 per cent." This is a very important innovation and it would be good to see work of that sort carried on and the removal of other toxic ingredients. If there is the science to do so, then the science should be applied across the board.

  107. So there would be a case for safer cigarettes on the level of carcinogens in them?
  (Dr Milner) I think the modern scientific community would prefer to look at particular toxic ingredients of tar because tar is a mass of many substances, but if we were able to look at the amounts of particular ingredients that we know to be toxic or carcinogenic within the tar and remove those from tobacco, once again we would be continuing down that avenue of trying to find a safer cigarette.

  108. I am aware of the fact, your paper made me aware of the fact, that there is more than one type of nitrosamine and I am not too sure which aspect of the chemical structure is the carcinogen. Presumably to make them nitrosamine-free would be something that was positive and ought to be tested for?
  (Dr Milner) My colleague has passed me a little bit of information which I should pass on to you. Nitrosamines are produced during pyrolysis of tobacco and we could produce a paper on this particular subject for you if that would be helpful.

  Mr Gunnell: I think that would be helpful, yes.

  109. Could I briefly touch on the issue of voluntary agreements, which has been referred to on a number of occasions so far. We have had interesting conflicts in our written evidence between various organisations writing to us about the impact of voluntary agreements. The tobacco manufacturers describe regulation by voluntary agreements as "flexible, speedy and effective". In contrast, ASH and the RCN have said that it is "ineffective and at times [has] amounted to `regulatory capture' by the tobacco companies". The implication is that you people have been captured by the tobacco companies on the basis of this voluntary regulation. What actually has been achieved by voluntary regulation? Going back to the first question I asked about the number of deaths that have occurred over the years, the impact of this product, I cannot see that a great deal so far has been delivered through this continuing voluntary agreement with the industry. Have I missed something?
  (Dr Milner) What you are touching upon is, has there been a health benefit from the voluntary agreements which have led to reducing the tar so that now the strongest tar cigarette nominally is 12 mg of tar, and this is still a debate. There are those scientists who believe that genuinely there has been some benefit, particularly in relation to lung cancer incidence and possibly coronary heart disease incidence. There are others who would question the amount of that benefit, to what degree has there been a benefit. Because we now know so much more about compensation, we have worries about the new types of tumours that are emerging and we have worries about the methodology of the studies that were carried out that appear to show that there has been a reduction in lung cancer, because those studies did not look, for example, at the socio-economic groups. They did not adjust for the socio-economic group of the smoker and we now know that poor smokers smoke differently and actually get more of the nasties out of the cigarettes than affluent smokers. So we have a lot of doubts but this is a debate that is raging at the moment and I cannot give you a clear steer.

  110. Do you defend the concept of voluntary agreements from your own experience? I am putting that to you, Dr Milner. I will bring Mr Baxter in in a moment.
  (Dr Milner) I sit here with the benefit of hindsight.

  111. We all do, of course.
  (Dr Milner) It seemed like a good idea at the time.

  112. But we still have them.
  (Dr Milner) We still have them but we have the hope now of tighter regulation through Europe and obviously ministers have decided that we will go down that route and we will do all we can to support the European Directive, which will bring in greater controls.
  (Mr Baxter) I wanted to touch on the voluntary agreement in terms of tobacco advertising and sponsorship. Until the current legal uncertainty is resolved, those continue and there ministers have made their position very plain, that they regard those voluntary agreements as lacking because I suppose the key problem is the enforceability. It is to a committee, COMATAS; it depends on people bothering to write in with a complaint; for every complaint there may have been many infractions of a voluntary agreement. So I think that certainly ministers made it plain that they felt that voluntary agreements in that area were unsatisfactory and so supported the Directive. I think we have all to make plain where we feel the existing voluntary agreement on additives is not satisfactory and again the Government made its position clear in the White Paper, that it supported European action to look at additives, labelling, etc. So I think, putting it generally, the present Government believes the voluntary approach in this area has not delivered the benefits it had hoped for. I think it was entered into in good faith and with hindsight, with evidence, we feel this has not delivered what we had hoped.

  113. Mr Lincoln, presumably you agree that the voluntary approach simply has not worked?
  (Mr Lincoln) Yes. I repeat what I said earlier, that we believe that if you are into conspiracy theory, the voluntary agreements have not worked. They would appear on analysis to have been breached in many ways and that is why we are advocating statutory regulation, particularly along the lines that are being proposed in the European Directive, and are advising the Government on that as well. Obviously that has happened with advertising now and we would like to see regulation in terms of, as other people said, labelling and constituents of tobacco in cigarettes and the like and additives and all the rest.

  114. It seems to me in particular quite clear that people only enter into voluntary agreements which have a benefit and I think that is a classic example of the tobacco industry doing that, and yet to give an example, what you said right at the beginning of this session was that 4 million people died in 1988 from smoking, that is, one in ten adults, and by the year 2030 one in six adults or 10 million a year will have died. So clearly voluntary agreements are working extremely well in the interests of the tobacco industry and clearly are not working so well in the light of the consumer. The question I want to ask, just to clear up one point without any equivocation, is, is there any potential at all to produce a safer cigarette or is the whole concept completely meaningless?
  (Professor Donaldson) You are going to get a personal opinion really because I do not think it is an appropriate strategy to pursue at all. We know that there is strong evidence that the majority of smokers want to give up; they cannot give up for a variety of reasons, including a strong element of addiction for adult smokers. We are confident that fewer children would take up smoking or would prolong their smoking beyond an experimental phase if they were not subjected to promotion and advertising on the scale that they have been in the past. We know that with people who have given up smoking their health improves, their risk of death and disability improves and they generally benefit. So I think all our actions should be targeted to getting people who are smoking to stop, helping them to stop and stopping children particularly from starting smoking.

  115. I entirely agree with everything you have said but to clear it up, do any of the witnesses feel there is any benefit whatsoever to a safer cigarette or should we simply be coming out with all guns blazing and saying there is no such thing as a safe cigarette, we have to abandon any thought of a safe cigarette and we concentrate entirely on reducing the burden of smoking in total?
  (Professor Donaldson) That would be my view.
  (Mr Lincoln) I agree with Professor Donaldson that that should be the policy but again there is a debate within the public health community.

  116. Is the debate in the public health community a debate that is fuelled by the concerns of the industry as to what the implications are of this idea of a safer cigarette, because if we have a safer cigarette all the other products are less safe?
  (Mr Lincoln) I think if an addictive product exists, and obviously we do not want anything that encourages further addiction, which comes back to the point that was being made earlier in relation to additives, then if we still have a core of people who are going to continue to smoke, one really has to look at whether harm reduction strategies should be continued and that the product should be made safer, and this is where disclosure comes in and the extent to which there is information about how to make those products safer.
  (Professor Donaldson) But if I could add, Chairman, very briefly, I think the whole concept, as I found in other fields of my advice to the public, of conveying the image of safety in this field could lead to more people thinking that they should continue smoking, so I think even the use of the term "safe" or "safer" is a risky one in this field.

  117. Do you think there should be further research carried out to reduce, for example, nitrosamines levels or carbon monoxide levels if the technology ever became available to do so? Do you think that should be pursued or do you think that is a fruitless strategy?
  (Professor Donaldson) No, I think the main emphasis on such a strategy of further scientific research on the components of cigarette smoke should be, first of all, to establish what are the ones that are in use for a particular brand of cigarettes and then to accumulate scientific evidence of their risks and then to let the public have access to that information as soon as it becomes available.
  (Dr Milner) I agree with everything that has been said about our main aim, but technically, yes, I think a safer cigarette could be produced. We have to think beyond just our own shores. We have huge problems in developing countries where there is very little control of tobacco companies' activities, marketing and promoting their products. There is no such thing as a safe cigarette, but to reduce mortality, if there is a technique to take out certain carcinogens, to move towards almost an improvement of the nicotine replacement and a reduction of the damage to the traditional cigarette so eventually you get a pure nicotine device (there are many people who will continue to smoke because of the addiction and worldwide we cannot simply say "Don't smoke"), of course that should be the public health message and we can take that message forward better in the developed countries in the Western world where we are doing a lot, but why should we not also at the same time try to reduce harm in other parts of the world. I believe it is possible to make a safer cigarette. It may not be the right moral route to take.
  (Professor Donaldson) The difficulty with that, though, is that it takes 20 years to find out whether it is safe or not. As we are starting to see with the low-tar brand, what was believed to have been a strategy for producing a safer cigarette probably has not worked.
  (Mr Baxter) I do not think anything based on something like a burning tobacco can ever be safe. There may possibly be some other delivery of nicotine systems which does not have the harmful side effects but I do not think they look anything like what we call cigarettes.

  118. The message coming forward from Professor Donaldson seems to be do not start and if you have started, stop. The Scientific Committee's report under the heading of "Addiction" seems to use the words "addiction dependency" and "habit" interchangeably. Would you accept that there is a very real difference between habit and addiction and dependency and that it is not helpful if we use those terms interchangeably?
  (Professor Donaldson) I agree with you, it does not help that the tobacco companies in their evidence have used the word habit and some people would take that to be a downgrading of the seriousness of the addiction that is caused by nicotine. I personally find habit an unsatisfactory term in this context.

  119. I want to ask about nicotine replacement therapy. My question is not addressed to the Health Education Authority, Mr Lincoln, because you have made your views very clear. You have said it is a paradox that the most dangerous form of nicotine delivery, the cigarette, is virtually unregulated, whereas its safest form, nicotine replacement therapy, is strictly regulated under the Medicines Control Agency. My question to the Department is, is there any justification for that disparity? We have partly touched on it and so if the answer you want to give is simply no then give it and then we will know where we are. If you think there is some reason for the disparity or some justification then tell us.
  (Mr Baxter) If you are asking us to justify tobacco being to a great extent unregulated, obviously we are not going to say that is a justification. I think we have already said we are where we are as a result of a long history. I think underlying your question is let us make NRT much more widely available and try and level the playing field.
  (Professor Donaldson) I think the only argument that could be mounted, although I am not sure I would want to do it, would be that in introducing smoking cessation programmes from a health point of view you are actively promoting the use of a product, nicotine replacement therapy, so you would have an obligation to make sure that that was safe and regulated, whereas we are not advocating the smoking of cigarettes, in fact exactly the opposite, but I agree with you that it is a difficult inconsistency.