The EPA will
continue validating its ToxCast screening tool by screening more than 100 drugs
provided by Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Merck, the agency
announced on Thursday, May 13, 2010. These drugs never entered the marketplace
because they demonstrated different types and levels of toxicity when the
pharmaceutical companies conducted the early stage clinical trials required by
the Food and Drug Administration as part of the drug development process.
The agency's researchers
will quickly screen the drugs and then compare those results with the clinical
trial results. Assessment of the similarities and differences in the results are
being used to help the agency screen chemicals for toxicity.
"For the first
time, we'll have both ToxCast screening data and results from toxicology
studies and human clinical trials," said Dr. Paul Anastas, EPA's assistant
administrator of the Office of Research and Development. "This is an
important step in accessing the treasure trove of data that the pharmaceutical
industry has in ways that helps protect human health and the environment."
Because of the high
cost and the long process of conducting chemical testing, only a small fraction
of the thousands of available chemicals have been assessed for potential human
health risk, the agency said. The EPA is using its ToxCast screening tool to
help understand how chemicals may impact processes in the human body that could
lead to adverse health effects. Currently, ToxCast includes 500 automated
chemical screening tests that have assessed more than 300 environmental
chemicals.
The clinical trial
data will help the EPA select the ToxCast screening tests and biological
profiles that are the most predictive. The tests and profiles will be used as
indicators of potential toxicity for future chemical screening. The ToxCast
screening results will be available online for scientists and the interested
public to use.
The collaboration between
the agency and the pharmaceutical companies was fostered by the International
Life Sciences Health and Environmental Science Institute. The organization
adopted the inclusion of failed drug candidates into ToxCast as their emerging
issue of 2009.
More information on
ToxCast is available at
www.epa.gov/ncct/toxcast/.
SOURCE: EPA Press release
