TY - JOUR
KW - 3Rs
KW - NAMs
KW - Three Rs
KW - animal testing
KW - history
KW - pharmaceuticals
KW - regulations
KW - safety testing
AU - Doortje Swaters
AU - Anne van Veen
AU - Wim van Meurs
AU - Janette Ellen Turner
AU - Merel Ritskes-Hoitinga
AB - The contemporary pharmaceutical industry is voicing growing concerns about the translatability and reproducibility of animal models. In addition, the usefulness of certain of the required regulatory safety tests in animals is being increasingly questioned. It remains difficult, however, to make the move toward alternative testing methods, not least because of legislative demands. A historical analysis was performed, in order to study how the mandatory animal studies in legislative requirements came about. This article reflects on the role that specific public health disasters played in the creation of (more) regulatory requirements for animal testing. It will show how the regulatory changes prompted by the sulfanilamide elixir disaster in the 1930s and the thalidomide disaster in the early 1960s were based on the belief that extensive animal testing would prevent similar future human health tragedies. As scientists increasingly highlight issues with translatability between non-human animals and humans, the belief that current regulatory requirements ensure safety becomes more difficult to maintain. In addition, it means that some of the regulations now in place require animal tests that do not contribute to the safety of a drug, as shown in a third case study of the court case by Vanda industries against the FDA. We finally argue that regulations should be critically examined and altered where necessary, so that they are no longer a barrier in the transition toward animal-free testing and more human-relevant science.
BT - Alternatives to Laboratory Animals
DA - 2022-08-19
DO - 10.1177/02611929221118001
IS - 5
LA - eng
N2 - The contemporary pharmaceutical industry is voicing growing concerns about the translatability and reproducibility of animal models. In addition, the usefulness of certain of the required regulatory safety tests in animals is being increasingly questioned. It remains difficult, however, to make the move toward alternative testing methods, not least because of legislative demands. A historical analysis was performed, in order to study how the mandatory animal studies in legislative requirements came about. This article reflects on the role that specific public health disasters played in the creation of (more) regulatory requirements for animal testing. It will show how the regulatory changes prompted by the sulfanilamide elixir disaster in the 1930s and the thalidomide disaster in the early 1960s were based on the belief that extensive animal testing would prevent similar future human health tragedies. As scientists increasingly highlight issues with translatability between non-human animals and humans, the belief that current regulatory requirements ensure safety becomes more difficult to maintain. In addition, it means that some of the regulations now in place require animal tests that do not contribute to the safety of a drug, as shown in a third case study of the court case by Vanda industries against the FDA. We finally argue that regulations should be critically examined and altered where necessary, so that they are no longer a barrier in the transition toward animal-free testing and more human-relevant science.
PY - 2022
SP - 322
EP - 329
ST - A History of Regulatory Animal Testing
T2 - Alternatives to Laboratory Animals
TI - A History of Regulatory Animal Testing: What Can We Learn?
VL - 50
SN - 0261-1929
ER -