Healthcare: German studies
Lindl T, Völkel M & Kolar R. [Animal experiments in biomedical research. An evaluation of the clinical relevance of approved animal experimental projects: no evident implementation in human medicine within 10 years]. [German]. ALTEX 2005; 22(3): 143-151.
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According to the German Animal Welfare Act, scientists in Germany must provide an ethical and scientific justification for their application to the licensing authority prior to undertaking an animal experiment. Such justifications commonly include lack of knowledge on the development of human diseases or the need for better or new therapies for humans. The present literature research is based on applications to perform animal experiments from biomedical study groups of three universities in Bavaria (Germany) between 1991 and 1993. These applications were classified as successful in the animal model in the respective publications (Lindl et al. ALTEX, 18, 171-178, 2001). We investigated the frequency of citations, the course of citations, and in which type of research the primary publications were cited: subsequent animal-based studies, in vitro studies, review articles or clinical studies. The criterion we applied was whether the scientists succeeded in reaching the goal they postulated in their applications, i.e. to contribute to new therapies or to gain results with direct clinical impact. The outcome was unambiguous: even though 97 clinically orientated publications containing citations of the above-mentioned publications were found (8 % of all citations), only 4 publications evidenced a direct correlation between the results from animal experiments and observations in humans (0,3 %). However, even in these 4 cases the hypotheses that had been verified successfully in the animal experiment failed in every respect. The implications of our findings may lead to demands concerning improvement of the licensing practice in Germany.

Lindl T, Völkel M & Kolar R. Animal experiments in biomedical research. An evaluation of the clinical relevance of approved animal experimental projects: No evident implementation in human medicine within more than 10 years. [Lecture]. ALTEX 2006; 23(2): 111.

Retrospective evaluation of the ethical review process for animal experimentation has been demanded for years. One main aspect in evaluating this system is in investigating whether the prospective cost-benefit-analysis that served as the basis for granting licenses for procedures can be regarded realistic when compared to the actual outcome of the scientific research. Previous investigations have indicated that the distress for the animals has commonly been underestimated in applications for granting a license, and that the majority of investigated research projects failed to deliver the envisioned specific scientific results. In the present study, we looked at the clinical significance of research projects in those cases where applicants suggested a concrete benefit for the cure of human diseases. Only those projects were taken into account where previous studies had shown that the results of the animal research applied had confirmed the hypotheses of the researchers. A retrospective citation analysis for 12 years was performed and the results were unambiguous: after analysis of more than 1000 scientific articles: It has become evident that none of the 17 analysed applications at three German universities led to any new therapies or had any clinical impact. According to Directive 86/609 (Art. 12/2), painful animal experimentation need to be “of sufficient importance for meeting the essential needs of man or animal” to be licensed. The results of our study verify that in specific cases the practice of licensing of animal research in Germany fails completely. With regard to the “benefit”-factor, authorities have to apply much more stringent criteria when certifying the importance of the proposed research. For this “cost”-factor, as indicated in previous studies, the basis for prospective assessment of pain, suffering, and distress has to be objectified. The authorities hardly ever raise any serious doubts about the significance of the proposed research. Our study confirms the need to change perspectives, approaches, and questions so they can be addressed by non-animal methods. This notion should be enforced by the authorities. From an animal welfare perspective, the main paradigm of the licensing practice has to be turned upside down: when there is any question about the relevance of an at least painful animal research the decision in doubt should be for the animal.

Lindl T & Völkel M. No clinical relevance of approved animal experiments after seventeen years. ALTEX 2011; 28(3): 242-3.
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In 2005 we published an assessment of the medical impact of 17 research projects involving animal experiments and their 65 resulting primary publications (Lindl et al., 2005). Here we extend the original review, which covered the years 1993-2004, to include the period from 2005 to March 2011.

We found 1,316 citations of the 42 primary publications arising from the 10 basic research proposals and 146 citations of the 23 primary publications arising from the seven applied research proposals. More than half the citations in each field were made in papers reporting other in vivo animal experiments. The citation maximum for basic research papers was observed in 1998 (129); for applied research papers in 1996 (29). The decline in citations of the original animal data to zero in 2010 exemplifies the lack of long-term impact of most animal experiments.

Of the citations to publications in the field of applied research, 132 were found in clinically oriented papers, of which only seven related the experimental animal data to therapeutic results in humans. Even these seven reviews or review-like publications did not provide evidence of a direct relationship between the data from animal experiments and human therapies. In some instances, the animal data did not predict the human response.