The scientific imperative: why human-centered models must replace animal experimentation?

This paper aims to deconstruct the ethical and scientific impasse of using animals in biomedical research by proposing a paradigm shift towards human-centered methodologies. The study employs a critical analysis of the current animal experimentation paradigm. It first presents a two-fold critique, evaluating the scientific deficiencies, such as the "extrapolation gap" and methodological flaws leading to translational failure, and the ethical inadequacy of the welfarist approach. Following this critique, the paper proposes a new framework based on three pillars: the adoption of New Approach Methodologies (NAMs), the modernization of regulatory and funding structures, and the promotion of a culture of ethical responsibility. The analysis is based on a review of existing literature and ethical frameworks. The analysis reveals significant scientific shortcomings in the animal model, primarily its low predictive value for human outcomes due to interspecies biological differences. Ethically, the welfarist framework is found to be insufficient, as it perpetuates the instrumentalization of sentient beings without granting equal consideration to their interests. The proposed paradigm, centered on human-relevant NAMs, is presented as a more scientifically robust and ethically sound alternative. The traditional "Three Rs" framework offers only incremental improvements and is insufficient to resolve the core conflict. A decisive shift towards a new paradigm that aligns medical progress with more predictive, efficient, and just methods is not only an ethical ideal but a scientific imperative for the future of biomedicine. This transition is essential for advancing human health while fostering a more responsible relationship with non-human animals.