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Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods
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Published on: September 19, 2012

The costly illusion of regulating unknowable risks.

G B Gori1

  • 1The Health Policy Center, 6704 Barr Road, Bethesda, MD 20816, USA.

Regulatory Toxicology and Pharmacology : RTP
|January 5, 2002
PubMed
Summary

Regulatory reliance on animal testing for human cancer risk assessment is scientifically unfounded and costly. A rational approach balancing socio-economic utility with human safety evidence is proposed for better resource allocation.

Area of Science:

  • Toxicology
  • Risk Assessment
  • Regulatory Science

Background:

  • Man-made toxic episodes necessitate regulation for substance safety, particularly for cancer-causing agents.
  • Novel substances lack human use data, creating uncertainty in safety evaluations.
  • Current regulatory practices rely on animal testing to predict human cancer risks.

Purpose of the Study:

  • To critically evaluate the scientific validity of using animal tests for human cancer risk assessment.
  • To highlight the limitations and challenges of extrapolating animal data to human populations.
  • To propose a more rational and resource-efficient regulatory framework.

Main Methods:

  • Analysis of the assumptions and biological/statistical differences inherent in animal-to-human extrapolation.

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  • Review of authoritative opinions, such as those from the National Academy of Sciences, on regulatory approaches.
  • Examination of the economic burden imposed by current regulatory processes.

    • Main Results:

    • Animal testing, filtered through numerous assumptions, fails to overcome insurmountable human/animal biological, exposure, and statistical differences.
    • Authoritative scientific bodies have repeatedly found the regulatory approach lacking factual or scientific justification, deeming it arbitrary.
    • The current regulatory process imposes a significant economic burden, exceeding total U.S. industrial after-tax profits.

    Conclusions:

    • The reliance on animal testing for human cancer risk assessment is scientifically unjustified and legally vulnerable.
    • A more rational regulatory approach is needed, considering socio-economic utility and scientifically relevant human safety evidence.
    • Reallocating resources towards evidence-based, human-relevant safety assessments would improve national resource utilization.