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Summary

The widely accepted Three Rs (reduction, refinement, replacement) in animal research are insufficient. Over-reliance on animal models causes human harm, necessitating development of new, non-animal testing approaches.

Keywords:
Three Rsalternativesanimal experimentsanimal harmsanimal modelsclinical trialsdrug testingharm–benefit analysishuman benefitshuman harmshuman variationinhumanitynew approach methodologiesspecies differences

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Area of Science:

  • Biomedical Research Ethics
  • Animal Testing Alternatives
  • Toxicology and Pharmacology

Background:

  • The Three Rs (reduction, refinement, replacement) framework is broadly accepted in animal research.
  • Historical warnings regarding animal model limitations (species differences, human variation) are often overlooked.
  • Current harm-benefit analyses predominantly focus on animal welfare, neglecting human benefit evaluation.

Purpose of the Study:

  • To highlight the human harm stemming from over-reliance on animal experiment data in biomedical research.
  • To advocate for a re-evaluation of the balance in harm-benefit analyses.
  • To emphasize the need for increased investment in New Approach Methodologies (NAMs).

Main Methods:

  • Critical review of the ethical and scientific implications of animal experimentation.
  • Analysis of current regulatory and scientific practices concerning animal models.
  • Discussion of challenges in implementing and validating New Approach Methodologies (NAMs).

Main Results:

  • Over-reliance on animal models in biomedical research leads to significant, often unacknowledged, harm to humans.
  • Vested interests and regulatory complexities impede progress in adopting non-animal testing methods.
  • Exaggerated claims about the readiness of New Approach Methodologies (NAMs) hinder their adoption.

Conclusions:

  • Greater recognition of human harm from animal testing is crucial.
  • Urgent development, validation, and application of non-animal approaches are necessary.
  • Addressing vested interests and regulatory hurdles is essential for advancing ethical and effective research.