MoreThe 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
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
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