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The Science of Alternatives:Initial Truths—
Current RealitiesJanuary, 2008
Alan M. Goldberg, Ph.D.Johns Hopkins University
Bloomberg School of Public Health
Initial Truths And Current Reality
Acetylcholine to Serine
1900s: Rat Introduced in Biomedical Research
1950s: AWI—Robert Gesell UFAW
Russell & Burch Book:The Principles of Humane Experimental Technique
Timeline
Replacement, Reduction,
Refinement
3 Rs Hypothesis:Humane science is the best science
1960s: US AWAPepper the dog
FRAME—Andrew Rowan
1970s: Animal Liberation—Peter Singer
1980s: Prof. Sugawara—JSAAE Henry Spira—Leading to Formation of CAAT
1990s: Initiation of World Congress From Baltimore MD USA to Tokyo, Japan Development of National Centers
2000s: Commercial Development of Alternatives: CROs 1st Meeting of National Centers – Baltimore, MD
Timeline
Acceptance of Animals in Biomedical Research
Okay to use 75-80%
If pain part of protocol?
decreases to less than 50%
Pain-freeAnimals
3 Rs
Alternatives
Humane Science
The Structure of Scientific Revolutions:
Role for HistoryEach of them necessitated the community’s rejection of one time-honored scientific theory in favor of another incompatible with it. Each produced a consequent shift in the problems available for scientific scrutiny and in the standards by which the profession determined what should count as an admissible problem or as a legitimate problem-solution.
—T. Kuhn
The Structure of Scientific Revolutions:
Role for HistoryAnd each transformed the scientific imagination in ways that we shall ultimately need to describe as a transformation of the world within which scientific work was done. Such changes, together with the controversies that almost always accompany them, are the defining characteristics of scientific revolutions.
—T. Kuhn
Incommensurable:
It is not possible to understand one paradigm through the conceptual framework and
terminology of another paradigm
Drivers for Alternatives
Initial Truth:
1980—Animal Protection Movement(It was the only driver)
Current Reality
ScienceEU legislation and Marketing BanREACH and California Legislation
NanotechnologyAnimal Protection Movement
(Societal Demands)
Drivers for Alternatives
Approaches to the Development of Alternatives
Initial Truths
1980s—Empirical cell assays, descriptive
One assay to replace one animal test
Rabbit Pyrogen Assay LAL Human RBC
Rabbit Pregnancy Testing Monoclonal Antibody
Approaches to the Development of Alternatives
Current Reality—Replacement
Basic ScienceProduct Development
Regulations (Scientifically valid vs. validation)e.g. Pesticide—8000-10,000 animals to
In vitro and non-mammalian tests.
Approaches to the Development of Alternatives
Current Reality 2—Replacement
Mechanistically based assaysTranslational toxicology
Batteries of In Vitro assays
Initial Truth
A necessity for acceptance Process driven, managed studies Once validated, everyone would use
ValidationValidation
Validation
Current Reality
Validation is only the first step in acceptance and implementation
Evidence Based Toxicology, Cochrane Collaboration Approach.
Successes
Initial Truth
“We will never have alternatives…”
Successes
Current Reality
Validated Alternatives
Alternative Centers: ~20 of them
Scientific Journals
Commercially Successful In Vitro Companies
NAS Report — Toxicology in the 21st Century
Successes
World Congress
Academic Departments / Endowed Professorships
13 REACH Projects• 264 Participants• 80 Million Euros• 171 Methods under Evaluation
Initial Truth
Science does not belong to one country
Current Reality
Science does not belongto one country
Initial Truth
Acetylcholine paper published in 1972
(Goldberg and McCamon) ~ 2000 reprints needed
a HUGE number
Current Reality
Altweb:
20-30,000+ Visitors/Month
http://altweb.jhsph.edu
Acceptance by Scientific Community
Initial Truth
1. Cardiac Care Unit2. AAAS3. First Report to Congress by NIH on Alternatives
1. National Toxicology Program Roadmap for the 21st Century
Specifically identifies the 3Rs
Cites AWA – minimizing pain & distress
Requires training in humane science for all NTP investigators/Contractors
2. NAS: Toxicity Testing in the 21st Century
Acceptance by Scientific Community
Current Reality
Biological Matrix of Research
Initial Truth
Biological Matrix of Research
Current Reality
Acknowledgements
There are so so many— I have been very fortunate
Thank you