Programs & Campaigns
A Voice for All Animals
NEAVS' Comments to the National Toxicology Program Interagency
Center for the Evaluation of Alternative Methods (NICEATM)
November 12, 2001
William Stokes, DVM, DACLAM, Director
NICEATM (MD EC-17), NIEHS
P.O. Box 12233
Research Triangle Park, NC 27709
Dear Dr. Stokes,
Ample evidence shows the benefits
of using non-animal alternatives in toxicity testing. A key
example is the work of the late internationally recognized
Swedish toxicologist, Björn Ekwall, MD, PhD. Dr. Ekwall
demonstrated that an inexpensive battery of human cell culture
tests was more accurate than cruel and lethal animal tests
in predicting human toxicity.
This one model of human cell culture
tests has proven to be considerably more accurate in measuring
and understanding toxicity than are the animal tests currently
used. The tests were evaluated in a 10-year, multi-center
study involving 29 laboratories in 15 countries, including
the USA, Japan, Canada, Mexico, England, France, Spain, Italy,
Germany, the Nordic countries and Russia.
Research such as Dr. Ekwall’s has
shown that animal testing, which animal advocates oppose as
painful and lethal to animals, is also flawed and misleading
science. In fact, the predictive accuracy of the LD50 tests
on rats and mice has been estimated by Dr. Ekwall’s team to
be only 60 and 65% respectively, while the non-animal tests
developed by Dr. Ekwall’s team, using human cell line cultures,
is 75% accurate in predicting human lethal toxicity.
Dr. Ekwall’s project was the result
of a collaboratively funded effort by animal advocacy and
scientific organizations in the U.S. and Europe. It is an
excellent example of how humane concerns and scientific advancement
can and must go hand-in-hand.
Using animals to assess the risk of
acute human chemical poisoning has serious shortcomings. Since
results are given only as a toxic dose, which is simply a
gross measurement of several different events, the test can
point out toxic symptoms, but cannot directly point
out toxic events such as specific organ damage.
Dr. Ekwall’s Cytotoxicology Laboratory,
Uppsala (CTLU)’s MEIC (Multicenter Evaluation of In Vitro
Cutotoxicity) project shows clearly that in vitro testing
will increase safety for consumers while sparing animals from
painful and certainly unnecessary deaths.
His important work is being continued
through EDIT (Evaluation-guided Development of New In Vitro
Toxicity and Kinetic Tests) focusing on converting the MEIC
findings into practical testing by further developing and
evaluating batteries of in vitro tests for acute and chronic
systemic toxicity.
The MEIC study demonstrated a high
relevance of using human cell tests that determine basal cytotoxicity
for estimating human acute toxicity. Two types of in vitro
tests are now being added to the existing test battery. These
new tests will be able to determine key kinetic events (such
as passage over biological barriers and biotransformation)
and crucial organ-specific mechanisms.
While today it is possible to use
in vitro tests to set a "starting dose" for lethal
poisoning tests, this does not go far enough. Non-animal tests
must be used to fully replace animal toxicity testing.
Please consider that it is far better to wait for results
from the EDIT program and other validation studies before
starting any large-scale toxicity testing that would be based
on invalid animal tests. Given that the animal model is ethically
indefensible and scientifically unsound, to continue to use
it as the cornerstone of toxicity testing is nothing short
of irresponsible.
Even if the chemical testing were
postponed for one or two years while waiting for
the validation of further in vitro tests, it is entirely possible
and likely that the testing still would be completed earlier
than if the chemical testing started today using
standard animal tests. And, equally important, the non-animal
tests would be more scientifically accurate, more predictive,
and a truer accomplishment of the aim of toxicity testing
– to protect human health and well-being.
Thank you for this opportunity to
comment on this issue of grave concern to both human and animal
health. We urge an immediate end to all animal toxicity testing
and the incorporation of in vitro non-animal models into all
existing and planned toxicity testing programs.
Sincerely,
Theodora Capaldo, EdD
President
New England Anti-Vivisection Society (NEAVS)
333 Washington St., Ste. 850
Boston, MA 02108
tcapaldo@aol.com
Cecilia Clemedson, PhD
Coordinator of the EDIT Programme
Scientific Advisor, NEAVS
Expertrådet AB
Högklintavägen 7
SE-172 64 Sundbyberg
Sweden
c.clemedson@cctoxconsulting.a.se
For further information, contact Melinda Everett, APR,
Director of Media and Public Relations: 617-523-6020 x17 or meverett@ma.neavs.com.
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