Animal trials

Research into a therapy for a genetic disease is a complex and time-consuming process that generally starts from the ‘basic’ research stage (when researchers focus on cell or even molecular systems to pinpoint the mechanisms underlying the development of diseases and discover approaches for preventing onset). When systems (drugs, genes, cells) that block the progression of the disease in basic systems are identified, before administering the therapies to patients we must test them to determine their efficacy and non-toxicity. To do so, we use a complex organism that is as similar as possible to that of the human being. This practice considerably lowers all risks relating to errors of formulation or administration. There are very many instances of medical progress over the last few decades that have led to recovery, or have alleviated the suffering of patients, yet this would not have been possible had fully justified, carefully conducted and accurate animal trials not taken place. Visit the Research4Life site, which provides a venue for the public, institutions, the media and scientists to constructively debate various issues in the field of biomedical research, including animal trials.

Do people have the right to kill animals in order to improve human health? Are a human life and the life of an animal of equal value? Extremist animal rights activists see no difference. But can we consistently sustain this position in practical terms? Is it really possible to completely avoid eating or using any kind of food, drugs, clothing or other objects that in any way entail killing of animals? Above all, should governments only consider the positions of extremist animal rights activists when making laws that will have a direct impact on human health?

The legal premise is that “While it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment”. The more extreme animal rights activists do not believe this to be the case, arguing that laboratory animals and humans differ, and what works or is toxic in one may not affect the other in the same way. On the other hand, most scientists are of the opinion that animals can be a satisfactory model for studying the mechanisms of diseases. The choice of species is not left to chance. It depends on the level of complexity of the species in question, our knowledge of that species, the extent to which it is ‘naturally’ prone to the disease being studied, or similarities between a given organ and its human counterpart. Mice, for example, share 85% of their genetic makeup with humans, and the functions of the genes are identical (rodents are probably at the root of the evolutionary tree that led to Homo sapiens). It has been estimated that animal models have a predictability of 70%, with this ranging from 30% in the case of skin to 90% in the case of blood. 30% of toxic effects are not predictable. Scientists need to make cell tests as effective as possible so that most projects can be terminated at this stage and only those that are extremely likely to be of therapeutic value to patients are continued.

The new Directive defines itself as “an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches”. Critics of this law claim that alternative methods (computerised simulations, in vitro tests) are already available. Others argue that not enough is being done to develop them and that industries are lobbying against their development. According to a large proportion of the scientific community, while such methods (e.g. computer-aided molecular screening for a preliminary evaluation of candidate drugs, or modern imaging techniques to monitor the progress of a therapy or the stages of a disease, without having to kill animals and using fewer of them) have contributed to limiting the use of animals, they cannot as yet completely replace animal trials. A single cell is not a whole organism, and a simulation will never reach the level of sophistication required for predicting all the possible variables linked to an organism’s reaction to treatment.

Laboratory animals actually constitute a substantial cost for research centres (they make up the second biggest item of expenditure after salaries and wages). They require care and attention, both for maintenance and treatment, and imply a certain degree of emotional involvement. There are also time-consuming bureaucratic procedures involved in the use of animals. If we really could do without animals, that would also mean a considerable saving in economic terms, an issue very close to the hearts of researchers, given the shortage of funding available.

This claim definitely has a strong impact on public opinion, because of the reference to pets, like cats and dogs. It is therefore very easy for animal rights activists to use this argument to get the audience on their side. But what does the law actually say? On the question of stray animals, it states that “Stray and feral animals of domestic species shall not be used in procedures”, except when there is an “essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health” or if “there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal”.

Given their genetic proximity to humans and their highly developed social skills, the use of primates in scientific procedures raises specific ethical and practical questions. As the law stands, based on current scientific knowledge, the use of non-human primates is still considered to be necessary. However, given the sensitive nature of the question of their use, this is authorised, “only in those biomedical areas essential for the benefit of human beings, for which no other alternative replacement methods are yet available. Their use should be permitted only for basic research, the preservation of the respective non-human primate species or when the work, including xenotransplantation, is carried out in relation to potentially life-threatening conditions in humans or in relation to cases having a substantial impact on a person’s day-to-day functioning, i.e. debilitating conditions.”

According to the law, “The choice of methods should (…) ensure the selection of the method that is able to provide the most satisfactory results and is likely to cause the minimum pain, suffering or distress. The methods selected should use the minimum number of animals that would provide reliable results and require the use of species with the lowest capacity to experience pain, suffering, distress or lasting harm”. The law also orders researchers to set “an upper limit of pain, suffering and distress above which animals should not be subjected in scientific procedures”. As far as the re-use of trial animals is concerned, the law only permits this if “the actual severity of the previous procedures was ‘mild’ or ‘moderate’” and if “it is demonstrated that the animal’s general state of health and well-being has been fully restored”.