Extrapolation of Animal Research Data to Humans: An Analysis of the Evidence

Abstract

The ethical arguments against animal experimentation remain ever-strong. In addition, the scientific case against the use of animals in research grows more compelling, with exponential progress in the development of alterna­ tive methods and new research technologies. The Dutch authorities recently announced an ambitious, but welcome, proposal to phase out "the use of labo­ ratory animals in regulatory safety testing of chemicals, food ingredients, pes­ ticides and (veterinary) medicines" by 2025, as well as "the use of laboratory animals for the release of biological products, such as vaccines" (Netherlands National Committee for the protection of animals used for scientific pur­ poses, NC ad, 2016 1 p. 3). National government departments ( e.g., the United Kingdom, UK, Home Office) have stated that alternatives to animals are now considered necessary for scientific as much as ethical reasons, also conceding that pressure exists within the research community to use animals in order to get published. Furthermore, only 20% of animal tests across the European Union (Eu) each year are conducted to meet regulatory requirements, with the vast majority carried out as basic research (including basic medical research) or breeding of genetically modified (GM) animals at academic institutions (European Commission, 2013b ). Despite the strength of both scientific and moral arguments, animal re­ search continues to increase worldwide, especially given the rising trend in use of GM animals. A Catch 22 situation also exists, with regulators largely refusing to break with tradition and continuing to accept only animal data, even when robust human-based data exists. Additionally, when new animal-free, human-relevant methods are developed, regulators often insist that research still be performed on animals; this is considered to be one of the major barri­ ers to achieving change and, in turn, results in an industry reluctant to invest