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Section C
Pain and Distress vs. Pain-Free Animal
Pain-Free Animals

Knock-out mice: genetically-modified animals that lack a specific
gene that has been “knocked-out” of the genome

A single-gene mutation is known within humans that causes a
congenital inability to feel pain in people who are otherwise normal

Work on knock-out mice lacking this gene is already underway
3
Are Pain-Free Animals Acceptable?

Survey to understand the acceptability of pain-free animals
-  Internet-based survey of 265 people from a wide range of
backgrounds, including animal welfare activists and scientists
using animals

Asked a series of questions relating to the acceptability of creating
and using pain-free animals
4
If Animals Unable to Feel Pain Were Created …
Gardner RM, Goldberg AM. Pain-free animals: An acceptable alternative? Proceedings of the 6th World Congress on
Alternatives & Animal Use in the Life Sciences. Tokyo, Japan. March 31, 2008. Available at: http://altweb.jhsph.edu/wc6
5
Intrinsic Value of the Animals

Something more than experience of pain and distress determines
people’s feelings about the generation and use of pain-free animals

We recognize that animals are sentient and have an intrinsic value

Laws are written to regulate pain and distress issues and do not
recognize intrinsic value of animals
6
The Tipping Point

Malcom Gladwell

Science writer from The New
Yorker

Tipping point: when an event
leads to sudden change

How do we think about events,
and why do we remember what
we do about events?

The tipping point has occurred in
in vitro toxicology
7
Why Now?

Number of chemicals: toxic ignorance

Diseases with unknown causes

Legislative mandate
-  Cosmetic directive, March 2009
-  California legislation
-  REACH

More humane, better science
8
Toxic Ignorance

1984: National Academy of Sciences study
-  Only 22 percent of chemicals have enough information in the
public literature to make risk-based decisions

1997: Environmental Defense Fund (Ellen Silbergeld)
-  71 percent of high production volume (HPV) chemicals lack
minimum toxicity data in the literature
-  We live in an age of “toxic ignorance”

EPA and American Chemistry Council independently confirmed
results
-  Only about 10–20 percent of the chemicals that we interact with
on a daily basis have basic hazard data available

Inspired legislative efforts and programs to collect this information
9
Solving Toxic Ignorance

Conducting standard toxicity tests (two-year animal studies) on up
to 80,000 chemicals is not feasible
-  Not enough human power and lab space
-  Not enough animals
-  Not enough money

Better methods must be found

Information is now required by legislation
10
Why Now?

Number of chemicals: toxic ignorance

Diseases with unknown causes

Legislative mandate
-  Cosmetic directive, March 2009
-  California legislation
-  REACH

More humane, better science
11
Diseases of Unknown Cause

Increasing incidence of many diseases
-  Breast cancer, prostate cancer, autism

Each has potential to be related to environmental chemicals

Without knowledge of the chemicals that we are exposed to, the
reality remains unknown
12
Why Now?

Number of chemicals: toxic ignorance

Diseases with unknown causes

Legislative mandate
-  Cosmetic directive, March 2009
-  California legislation
-  REACH

More humane, better science
13
Legislative Mandates

European legislation
-  Cosmetic Directive, 7th amendment
  Cosmetics and their ingredients should not be tested on
animals
  Cosmetics cannot be sold in Europe if it or its ingredients
have been tested in animals anywhere in the world
  Ban will be phased in starting in March 2009: acute
toxicity, skin-sensitivity, and eye-irritancy must be done in
vitro
  March 2013: must be able to do complete risk assessment
for cosmetic ingredients with in vitro methods
-  REACH
  Registration, evaluation, authorization, and restriction of
chemicals
14
Why Now?

Number of chemicals: toxic ignorance

Diseases with unknown causes

Legislative mandate
-  Cosmetic directive, March 2009
-  California legislation
-  REACH

More humane, better science
15
Humane Science, Better Science

Pre-2000 clinical studies
-  35 percent of clinical studies failed due to inadequate
knowledge of metabolism

Post-2000: in vitro human cells
-  5 percent of clinical trials failed due to an inadequate
knowledge of metabolism

Currently: FDA requires metabolic studies of human cells in culture
16