HC Deb 11 December 1975 vol 902 cc285-91W
Mr. Lamborn

asked the Secretary of State for the Home Department if he has received the report of the Advisory Committee on the Administration of the Cruelty to Animals Act 1876 about experiments in which dogs are used to test a tobacco substitute; and whether he will make a statement.

Mr. Roy Jenkins

Yes. The Committee has recommended that the experiment, which has been in progress for three years at ICI, should be allowed to continue, but that authority to begin similar experiments elsewhere should be refused. It found nothing to criticise in the treatment of the dogs on grounds of cruelty and it rejected the argument that animals should not be used to find ways of alleviating "avoidable" suffering in man. It was satisfied that the scientific justification for the experiment existed at the time the experiment began and that, in the case of an experiment which has been in progress for three years, such results can be expected to be obtained as would make it wrong to terminate it prematurely. The latest state of scientific knowledge, however, does not justify the beginning of any similar experiments.

I have accepted the Committee's recommendations and have taken the necessary steps to implement them.

The text of the report of the Committee, with the exception of annexes, the publication of which would infringe commercial confidentiality, follows. I would like to take this opportunity of thanking the Committee for its work.

"Dear Secretary of State

You have referred to the Advisory Committee on the Administration of the Cruelty to Animals Act 1876 two cases involving the use of dogs to test a tobacco substitute. One experiment has been in progress for over three years and the other has not yet started. In both cases the licensees concerned, Dr. Conning and Dr. Clark, already held the necessary licence and certificates under the Act and to that extent the situation is unusual since the Committee's advice is normally sought only in respet of experiments for which consent has not yet been given.

2. Dr. Conning's work at the Central Toxicology Laboratory of Imperial Chemical Industries at Alderley Park, Cheshire, aroused considerable public and Parliamentary interest at the beginning of the year following an article and photographs in a Sunday newspaper and it was largely because of this that the matter was drawn to our attention. Dr. Clark's proposed work as Inveresk Research International, Midlothian, has not attracted similar publicity in England, though it has in Scotland. Since both projects have many identical or similar features—indeed we understand that Dr. Clark designed and inaugurated the ICI project—much of what we say applies to both.

3. As we see it three distinct questions arise for consideration: (A) whether the dogs at Alderley Park are being "treated with cruelty" in the ordinary sense of the word, (B) whether it is morally justifiable to train dogs—or indeed any other animal—to lead an unnatural life in order to discover a safer substitute for tobacco and (C) whether there is a reasonable likelihood of these experiments leading to or helping in the discovery of such a substitute and whether it is reasonably necessary to use dogs for the purpose.

The cruelty question

4. In the ICI experiment forty-eight beagle dogs are used. The dog's muzzle fits into a fixed airtight mask. The mask is equipped with an airway, a cigarette holder and a valve to connect the dog to one or the other. The valve is operated electronically to a predetermined set of parameters determined by the dog's own breathing pattern and the exposure to smoke which it is desired to achieve. During exposure the animals are provided with a sling which acts as a kind of hammock if the animal wishes to relax, but otherwise allows the animal to stand or sit. There is a head restraint, but it allows the dog to move its head freely, and—as some of us saw—occasionally to withdraw it entirely from the mask. Drinking water is within easy reach of the dogs. Twelve dogs inhale tobacco smoke, twelve the smoke from the experimental new smoking material, twelve the smoke of a 55 per cent./45 per cent. mixture of the two and twelve breath air but are fited with the mask and subject to the same restraints as the rest. The dogs that smoke smoke 30 cigarettes a day over a six-hour period, 5 days a week. They receive a two-second puff of smoke every minute (with fresh air during the interval) and have a forty-five minute break in the middle of the day.

5. A number of members of the Committee, including the chairman, visited Alderley Park in three separate groups to see the experiment for themselves and to talk with those concerned with it. They would like to record their appreciation of the ready co-operation at all times of the Company and its staff. We have no hesitation in saying that in so far as any reports which have appeared in the Press or elsewhere suggest that these dogs being "tortured" or are "in pain" or are being subjected to cruel treatment they are wholly misleading. It is, of course, true that they are not leading an ordinary dog's life but then they are not ordinary dogs. They were specially bred by the Company at Alderley Park for laboratory use and only those which proved temperamentally suited to the constraints involved in the experiment were used. The dogs had clearly established a good relationship with their handlers whom we saw and to whom we spoke and they showed no signs of fear or distress. We would indeed have been surprised if we had found anything to criticise on grounds of cruilty since the experiment has from the outset been regularly inspected by Home Office Inspectors.

The moral question

6. It is a requirement of the 1876 Act that every experiment under the Act must be performed with a view to the advancement by new discovery of physiological knowledge or of knowledge which will be useful for saving or prolonging life or alleviating suffering. It is also provided that experiments not involving complete anaesthesia should not be performed on cats or dogs unless it is essential for the success of the experiment that these particular species should be used.

7. The case presented by ICI on which the licences and certificates were granted may be summarised as follows:

Each year a large number of people die or suffer from lung cancer, bronchitis, emphysema and cardio-vascular diseases mainly attributable to or exacerbated by smoking, particularly cigarette smoking. Steps have been and continue to be taken to persuade people to give up or curtail the habit. It must, however, be accepted that the habit will persist and that consequently the suffering and death it causes will continue on an appreciable scale for the foreseeable future. In these circumstances it is very desirable that a smoking material be developed which has no or demonstrably fewer toxic effects than tobacco. The ICI and other similar experiments are steps on the road to the successful development of such a substitute or substitutes, and so are aimed at the saving or prolonging or life or the alleviation of suffering. It is essential to "try out" any substitute on some animals in order to find out whether or not it has any noxious side effects and dogs are the species best suited for the purpose.

8. The argument against this thesis which is generally advanced is that the suffering referred to in the Act ought to be interpreted by the Home Office as excluding avoidable suffering, a category into which suffering arising from the self-inflicted exposure of lungs to tobacco smoke clearly falls. The way to reduce the incidence of disease associated with smoking is either to prohibit smoking or to make it more difficult for people to smoke by banning the manufacture or import of cigarettes. If despite all such measures and constant warning people go on smoking they have only themselves to blame and should pay the price of their own folly.

9. We are not in fact at all sure that it is right to regard all suffering from smoking as self-inflicted, for there is some evidence that a pregnant woman who smokes to excess may hazard the life or well-being of her unborn child and that many people, including children, live, work and spend their leisure in a smoke-laden atmosphere which may be injurious to them and is not of their making or seeking. But even apart from this consideration we think that it would be wrong in theory and impossible in practice to put such an artificial limitation on the meaning of the word "suffering" as used in the Act. It is probably true that a great of suffering may be avoided or mitigated by the adoption of a "sensible" way of life. Obesity, venereal disease and injuries in road accidents are obvious examples of largely avoidable suffering. It must be remembered, however, that it is no part of the function of the medical profession to make moral judgements in determining whether or not or how to treat the conditions which come to their notice. It is moreover often in practice simply not possible to determine with certainty whether a particular condition is "natural" or "self-inflicted".

10. We recognise, of course, that any use of any animals for experimental purposes raises issues on which widely divergent views are held. We have not been asked to express a view on these broader issues, a consideration of which would lead us far beyond these particular experiments, and all that we would say is that so far as we can see there is nothing in these experiments (save the fortuitous publicity attaching to them) which distinguishes them in any relevant way from many other experiments for which authority is commonly given. It follows that if there had been no doubt that the "scientific" question could be answered in a sense favourable to ICI we would see no reason to advise a withdrawal of the authority.

The "scientific" question

11. Even before we heard expert scientific evidence some of us doubted whether an experiment involving only 48 dogs over perhaps 3 to 5 years was likely to yield conclusive results which, coupled with other experiments not involving dogs, would justify marketing a product designed to replace a known toxic substance the effects of which became evident only after 20 or 30 years of habitual use. It looked, that is to say, as though experiments with more dogs over a longer period might be needed to achieve worthwhile results.

12. In accordance with the wish which you expressed in referring the question to us we consulted the Independent Scientific Committee on Smoking and Health, which we shall refer to in this report as the Hunter Committee after its Chairman, Dr. R. B. Hunter, Vice-Chancellor of the University of Birmingham. The initial evidence which they gave us left us in no doubt on two points:

  1. (a) that when the applications were made and certificates granted it was entirely reasonable to think that it was only by the use of dogs that tobacco substitutes could be satisfactorily tested; but
  2. (b) that as a result of further knowledge gained by the Committee in the course of the last two years or so they had formed 289 the view that adequate toxicity tests of tobacco substitutes could be made without the use of dogs.

13. In their "guidelines" for the assistance of manufacturers of tobacco substitutes published shortly after they had given evidence to us the Hunter Committee set out three stages of testing which they consider necessary. Stage 1 involves "short term" acute studies in rats and monkeys. Stage 2 involves "short term" clinical tests in man. Stage 3 involves "long term" studies in various small animals—i.e. skin painting in mice, teratological studies in rats and inhalational studies in rats and a second species which could be hamsters. In his evidence given to us Dr. Hunter did, however, say that although dogs were not now thought necessary in toxicity tests it might be that a case could be made out for their use for other purposes—e.g. cardio-vascular tests—and that it was for that reason that the guidelines while not mentioning dogs did not specifically exclude them.

14. The evidence given by the Hunter Committee obviously raised a doubt whether what we have called the "scientific" question ought now to be answered favourably to ICI. Accordingly we put before ICI the substance of that evidence and invited their comments on it. We then put their comments to the Hunter Committee for them to answer. Copies of the correspondence and of the guidelines are annexed to this report. The main arguments on each side are summarised in the following two paragraphs.

15. ICI said that in their view it was essential that any programme of experimental investigation of a tobacco substitute should include investigation of the effects of inhaling undiluted smoke through the mouth for a large part of the life span of the animal used—in close approximation to the smoking pattern in man. This limited the choice of species to the dog and the primate. They gave various reasons for considering that the dog was preferable one of which was that the dog is liable to develop pulmonary and cardio-vascular disease similar to man and is the only species so far in which lung tumours similar to one of the types found in man have been produced by direct exposure to tobacco smoke. They said they had noted no reent publications supporting the view that rodents alone were adequate in an examination of the inhalation toxicity of tobacco substitutes and did not see how such a conclusion could be reached in the present state of knowledge in which the nature of so many of the biological reactions to smoking is still obscure.

16. The Hunter Committee in its reply pointed out that in its guidelines it had concentrated on the pathological effects on the respiratory tract and lung function. It reiterated—and supported by reference to recent experiments—its view that the use of the rat and the hamster in inhalational toxicity studies could produce valid comparative results within two years which it would be willing to accept as evidence in its assessment of substitute tobacco. It dealt with ICI's point as to pulmonary and cardio-vascular disease in the following paragraph which we would quote in full. The Committee would not disagree with ICI's statement that the dog may be liable to develop pulmonary and cardio-vascular disease after a sufficient exposure period to tobacco smoke. As the animal is amenable to dosing with undiluted smoke, the choice of the dog is understandable. The Committee appreciates that the dog is a suitable model in respect of the production of squamous cell bronchial carcinoma similar to those found in man but not found in smoke-exposed smaller mammals. The Independent Scientific Committee has not in its guidelines for animal studies specified cardiovascular end points as it is the Committee's opinion that the relationship between cigarette smoking and cardio-vascular disease has not been adequately demonstrated in animal models.

17. In the light of what we have set out in the last five paragraphs the giving of an answer to what we have called the "scientific" question is not altogether easy. The certificates in question were allowed on the footing that a tobacco substitute could not be safely marketed unless it had been "tried out" on dogs. This was undoubtedly a reasonable view to take when the applications were made and acceded to. Now, however, the Hunter Committee has said that dogs need not be used for "toxicity" testing of a tobacco substitute. The scientific advisers of ICI do not agree with this view; but we assume that the Home Secretary in considering any new application for a licence to use dogs in experiments with regard to a tobacco substitute would proceed on the footing that the view of the Hunter Committee was correct. Dr. Clark has not yet started work on his project at the Inveresk Research International and we, therefore, recommend that as matters stand he should not be allowed to proceed with it. If he still wishes to go on with it he should make a fresh application for the necessary certificates based on an alleged need to use dogs for some purpose other than "toxicity" testing. If and when any such application is made it will have to be considered on its merits entirely de novo.

18. The ICI experiments on the other hand stand on a different footing. They have been in progress for over three years and as we have said we are satisfied that they involve no cruelty to the dogs. It is true that the relevant authority was granted on a view as to the need to use dogs for "toxicity" testing which may have been superseded by later experience; but even so we do not think that the Home Secretary would be justified in halting the experiments, with the result that the work and money already put into them would be wasted, unless he was fully satisfied that the experiments when completed could not result in the acquisition of knowledge which would be useful for alleviating suffering. In face of what the Hunter Committee says in paragraph 5 of its replies to the comments of ICI quoted above we do not see how the Home Secretary could be so satisfied. Indeed Dr. Hunter himself in the course of his evidence told us that it was his personal view that the ICI experiments should be allowed to continue. Accordingly we recommend that Dr. Conning be allowed to continue his work under the terms of the licences and certificates he holds, subject as in all cases to periodical inspection by the Cruelty to Animals Inspectorate.

19. The members of your Advisory Committee are unanimous in both recommendations. All have seen this report and have asked me to sign as their Chairman.

Yours sincerely,