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ANIMAL PROCEDURES COMMITTEE CONSULTATION ON THE COST/BENEFIT ASSESSMENT
Posted 1 January 2001
The Animal Procedures Committee of the Home Office recently issued a consultation paper on the cost/benefit assessment and the Animals (Scientific Procedures) Act 1986. They asked for comments. This is Animal Aid's response. The consultation paper can be viewed on the APC's website at www.apc.gov.uk.
We would encourage anyone, with or without scientific qualifications, to respond to the APC on any or all of the points that they raise. You can, of course, use our response as a guide; we have numbered the questions even though they are not numbered in the paper.
If you have particular expertise in any of the areas under consideration, your comments would be especially welcome. If you know anyone who does, please forward this to them.
This is an extremely important opportunity to have the regulatory authorities consider the very scientific validity of animal experiments: the crux of the whole issue as far as scientists and the government are concerned. We know animal experiments are scientifically invalid: it is imperative that we convince the APC of this fact too.
The deadline is 28 February 2001.
Please reply to email@example.com or to
Animal Procedures Committee, Room 978, 50 Queen Anne's Gate, London SW1 9AT.
You do not need to answer all of the questions; comments on any one will be worthwhile.
Animal Aid believes that from a moral stand-point, the validity of experiments on animals can be argued in absolute terms, inasmuch as it is morally wrong to capture, incarcerate or experiment on any animal for the benefit of humans or any other animals.
From a scientific standpoint, the validity of experiments on animals could and perhaps should be argued on a case by case basis. However, it is hard to imagine any exceptions to the absolute position that animal experiments are not valid in terms of application to human medicine, toxicology or pharmacology: for, as paragraph 7 says, animals are often not valid models of human disease. Equally, they do not adequately model human responses to medicines or poisons. Animal Aid does not consider any educational use of animals or their tissues justifiable in view of the range of excellent resources available to replace them in every context, eg. computer models and simulations, human tissues and microbial cultures, etc. If the research goal is the study of the animals themselves, then studying captive animals subject to the stresses of handling, confinement, artificial diets, etc. (which has been shown to significantly affect their immune and endocrine systems) has little scientific validity for extrapolation, even to the same (non-incarcerated) species.
The criteria used to assess validity should include a thorough assessment of the desired benefits. Are the supposed benefits real, ie. significant and novel? Could the benefits be obtained in any other way, eg. from plants, microorganisms or clinical observation/donated human tissue? It is fortuitous discoveries in clinical situations that produce benefits applicable to humans; fortuitous discoveries in animals will only have relevance for that animal.
The cost-benefit assessment clearly does not adequately address the scientific validity of experiments, as evidenced by the wealth of published research which is unjustifiably cruel, potentially hazardous, ill-conceived, repetitious or trivial.
As just one example, on what criteria could Imutran's xenotransplantation research programme, in which transgenic pig organs are transplanted into cynomolgus monkeys and baboons, have possibly passed a cost-benefit assessment?
The costs to the animals involved, both the piglets and the primates, are so high that this alone should have meant the experiments were not permissible if the cost-benefit assessment had any meaning at all. These costs have documented by the researchers themselves and exposed by Uncaged, in the Daily Express and on the internet, before Imutran obtained an injunction preventing further exposure of the massive animal suffering involved (see www.xenodiaries.org).
The risk of introducing new disease agents into people via animal organs is so great and so potentially devastating that this should have ruled against the experiments in any cost-benefit assessment.
As mentioned above, in any meaningful cost-benefit assessment the claimed benefits should also be subject to careful analysis. In the case of xenotransplantation, a false picture has been presented to the public by the commercially vested interests (Imutran and others). Based on the research to date, there is no demonstrable expectation of increased life expectancy for any prospective future human patient, and certainly no expectation of improved life quality - in view of the punishing immunosuppressive regime. If organ transplantation is the perceived remedy, increasing the availability of human organs is a far more rational and safer course. Health promotion measures are more important, in order to reduce the incidence of organ failure in the first place.
The Ethical Review Process is, in theory, a good place to assign responsibility for assessing validity but, in practice, it merely serves to legitimise the illegitimate. There are simply not enough people with appropriate expertise to consider alternative methods and to assess the scientific worth of the desired results available to sit on every Ethical Review Board in every research establishment.
Animal Aid believes that public funding bodies, such as the research councils, should not fund animal experiments which could be conducted with donated human tissue or organ-culture - or in other ways which do not involve the use of animals. In fact to conduct such experiments using animals where non-animal methods are available is in breach of Section 5 (5) of the Animals (Scientific Procedures) Act 1986 and EU Directive 86 / 609. The latter states that 'an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of the animal, is reasonably and practically available'.
The aforementioned funding bodies should therefore also have clear responsibilities for assessing validity, and could do much to encourage greater acceptance and use of alternative methodologies.
Animal Aid believes that the use of any animal species in any type of procedure involving incarceration and/or suffering is unacceptable. Clearly, though, in the perception of the majority of the population at least, some experiments are even less acceptable than others.
Animal Aid, New Scientist, Mori and others have commissioned opinion polls which reveal that most people feel an instinctive abhorrence towards certain categories of research and the use of certain species of animals, regardless of any potential benefits to be obtained. The following list identifies those types of experiments in most urgent need of abolition according to public sentiment:
- All types of weapons research, whether categorised as defensive or offensive;
- Household and industrial product testing (people know there are alternative tests and that certain substances cannot be made entirely safe and must therefore be used with caution);
- Psychological research, as it is willfully cruel and palpably irrelevant to people;
- The use of higher mammals, especially all primates, cats and dogs.
Animal Aid believes that mere scientific curiosity, or 'the acquisition of general biological knowledge' according to paragraph 7, is not of sufficient benefit to justify the use of animals.
The vast bulk of toxicity testing would also qualify as too trivial to justify the use of animals when the proposed benefit amounts to nothing more than a new variety of washing powder, a new perfume, a different sweet flavour, or a different brand of medicine for which there are already several generic versions.
Clearly, all relevant harms are not identified by current HO practice, or the documented examples of suffering obtained through undercover investigations would never have been allowed to occur. Many of those harms are mentioned in the next question. There is certainly a pressing need for clarification of the criteria used to weigh those harms and explain their assignment to 'mild', 'moderate' or 'substantial' categories. Such labelling clearly affects the weight proposed 'procedures' are given in the assessment process. For example, procedures for the production of founder stock and the breeding and maintenance of GM animals are assigned to the mild severity category. This is despite the fact that they involve injections of powerful hormones into very young animals and the subsequent killing of those animals in order to produce GM offspring, whose welfare status cannot be predicted in advance.
The major surgery and subsequent immunosuppression until death endured by the cynomolgus monkeys and baboons who were used for Imutran's xenotransplantation programme were classified as 'moderate'. Animal Aid would like to know how much more substantial suffering can be. The harrowing documents exposed by Uncaged revealed animals suffered from sickness, diarrhoea, tremors, open suppurating wounds and unimaginable distress for the duration of their post-operative survival. We must assume this is considered to be quite normal and acceptable to the HO, as the Minister concerned has declared that such shocking evidence does not even warrant a special investigation, let alone an independent inquiry - merely a 'routine assessment'. This is despite the fact that the animals concerned were primates (many of them wild-caught), perceived by the public as being afforded the highest level of government protection and care.
There is a large volume of scientific literature that seeks to define and calibrate the suffering and distress experienced by animals in laboratories. But such assessments will always be difficult and subjective: some people simply do not recognise the symptoms of pain or distress in animals. Depressingly, this means animals are frequently pushed to the limit - often overlooked by a stretched Inspectorate.
Animal Aid does not believe that the costs involved in terms of physical and psychological suffering associated with capture, confinement, transportation, social isolation, husbandry systems and general handling of animals are given their due weight. To afford due weight to the mental anguish all of the above must cause would require an empathy with the animals which is complete anathema to anyone who finds animal experimentation justifiable.
Death should most certainly be considered a harm. Indeed it is the ultimate harm which, if it were given due weight in the assessment, would preclude any experiments involving the death of the subjects. In the meantime, methods of killing are in urgent need of reform. Smashing rodents' and rabbits' heads on benches, or decapitating them by guillotine - both currently common and acceptable practice - cannot be considered to be humane. How many of the APC would euthanase their child's pet hamster in this way?
There are most definitely welfare problems specific to transgenic animals. These fall into two major categories: (a), the production of transgenic (GM) strains, and (b), the compromised welfare suffered by the transgenic animals once they are produced.
Regarding point a), the level of 'wastage' of animals in the production of GM strains is phenomenal: when new genes are injected into an embryo, the proportion of resulting animals who take up the gene can be as low as 1% - the other unwanted 99% are destroyed. In addition, for every GM animal produced, as many as 200 'donor' and 'recipient' animals undergo hormonal injections (which can cause painfully enlarged ovaries); major surgery to implant the embryos; and death, as soon as the required embryos are retrieved from them. Most of these animals are not even recorded in the HO statistics, as they have not undergone an officially recognised 'procedure'. This is despite having been confined in a small, barren cage, forcibly mated, and killed as soon as they have given birth to the offspring for which they were merely a disposable vessel.
Regarding point b), the 'successfully modified' animals (generally identified by cutting off and examining the tips of their tails) will suffer in a variety of ways. They will suffer the intended effects of their gene insertion/deletion. This might be a disorder supposedly analagous to the human ailment being modelled, or it will be the loss of organs and/or their functions, as a result of one or more genes being 'knocked out' in order to discover their function. Thus, mice have been produced without legs, eyes, or with grossly deformed organs.
In addition to these intented defects, a significant proportion of transgenic animals also suffer invisible, internal abnormalities, which may go completely undetected, which may manifest themselves in subsequent generations, and which are entirely unexpected and unpredictable results of the imprecise and uncontrollable insertion of the transgene into the genome of the host.
The APC really must address this type of research, which is accelerating at such a frightening rate that it has already reversed the steady decline in animal usage which has been so hard won over the past 20 years. Just because the animals are mainly mice, does not mean they have no need for proper care and protection: mice are sentient mammals and, as such, deserve to be treated as more than just 'fuzzy test-tubes'. Neither must they be viewed as a 'practice run' before moving on to higher mammals of supposedly greater utility. Here, however, we have already been overtaken by events and we are now faced with the spectre of GM primates; Andi being the first, no doubt, of many in America. This must not be allowed to happen here: we must recognise that this agenda is being driven by very powerful business interests and not by purported therapeutic need.
Recent research in transgenic mice has demonstrated that the hazards of genetic modification can be completely unexpected and extremely serious: attempts to engineer a contraceptive vaccine, instead produced a deadly virus which killed all the animals in the experiment. The implications for a major bio-hazard within or beyond the research community are chilling to contemplate.
Animal Aid considers the costs inherent in transgenic animal research will always outweigh the supposed benefits, which are exaggerated beyond the bounds of credulity.
For a decade or more, biotech companies have been claiming imminent human health benefits from the use of transgenic animals for the production of 'therapeutic proteins' in milk or eggs, ie. gene 'pharming'. The companies concerned have still not delivered. Apart from the potential hazard to the human population arising from contamination of the protein products with undetected animal pathogens, these products could much more sensibly and safely be produced in microbial culture or in transgenic plants. Therefore, the considerable costs to the animals involved indisputably outweigh the benefits, which could be better obtained elsewhere.
The likelihood of genuine benefits accruing from such a fundamentally flawed methodology as animal models of human disease is far too remote to outweigh any costs to the animals at all.
The risks to humanity of transplantation of transgenic animal organs into people (the transmission of novel viruses and other pathogens, for example) are so enormous as to render any benefits insignificant.
There is a very significant problem with the international trade in animals for research. Huge numbers of animals are posted around the world, alive and often pregnant, with little regard or provision for their welfare in transit. There is clearly also a significant risk of biohazard with such practices; not least because animals - or products made from their bodies or excretions - are often inadequately packaged, labelled and handled.
The transport of animals destined for laboratory use demands urgent attention. International trading in animals for research purposes should be banned for reasons of both animal welfare and human safety.
Comment on the attached annex
It is clear from this strange annex that the presumption of the APC is very much in favour of the animal model for medical research. A main message seems to be that had researchers not induced heart attacks in animals in laboratories, it would not have occurred to them to investigate platelet distribution in human cardiac patients - strange indeed!
If we were to attach an annex detailing examples of clinically valuable medicine being derailed by animal research, or of human toxicity not predicted by animal tests, or of animal research with no relevance or applicability to the human condition, or simply of biochemical and physiological differences between humans and other animals, it would be the size of an encyclopaedia.
Animal Aid believes the intellect of the scientific community is being undermined by the continued use and acceptance by the regulatory authorities of the so called 'animal model'. Other, more modern methods would be far more appropriate, they would yield higher quality research, and would be readily adopted by researchers were they to be given adequate financial and regulatory encouragement.
Written by Kathy Archibald, Scientific Researcher for Animal Aid.