Human models for human drug development
FRAME (Fund for the Replacement of Animals in Medical Experiments) has been working in this field for more than 50 years, and we know that the development of non-animal research techniques is a necessary part of improving the quality and efficacy of our drug development process, but that on their own, the existence of alternative methods is not sufficient to create change in such an entrenched area of scientific practice. FRAME is therefore adopting a systems thinking approach to looking at the problem, and believe the answer, in the truest nature of scientific advancement, involves incremental small advances in a number of areas which will need to build over many years to create a fundamental shift away from the reliance on animals.
This article discusses the need for a shift in ‘replacement’ thinking, what needs to be done to make responsible, reproducible, human-relevant approaches a first choice for research teams across industry and academia, and what part we believe industry insiders can play.
Animals have been used in mandatory product safety testing since the 1930s and it is still necessary for drug companies to use them to demonstrate the safety and efficacy of compounds to regulatory bodies such as the FDA, MHRA and EMA.
However, in a proportion of cases, using animals is an unreliable predictor of drug safety and efficacy in humans. There have been many examples of drugs failing in humans after being deemed efficacious and safe in animal tests, such as the anti-inflammatory drug, Vioxx and the diabetes drug Avandia.
There is a lot to do to fully embed human-focused methods in the drug development and testing process, and organisations and agencies need to work together to play a part. Global drugs companies are in an influential position to challenge the system and push for changes that, in the longer term, will be more economical, humane and better for human health.