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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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"No, there isn't," Healy replied.


While Parisian was testifying, the jury was shown an email dated March 30, 1994, with a discussion about the Japanese government asking for specific information about behavioral changes in babies exposed to Paxil and the protocols for a study that was being designed to respond.


The last sentence read to the jury stated: "Gwyn Morgan will be responsible for the review and the analysis of the protocols to ensure that a likelihood of any potential negative outcome is minimized."


The goal of pharmacovigilance is not to minimize risk, "particularly when the Japanese government is concerned about the risk," Parisian told the jury.


The purpose of doing pharmacovigilance and safety surveillance, in terms of toxicology, she said, "is to identify risks so that it can be addressed."


"And in terms of pharmacovigilance, animal study feeds into the information you have about outcomes of infants," she told the jury.


In 1997, Glaxo teratologist, Patrick Wier, conducted the rat study, with Segment one comparable to women in the first trimester of pregnancy, and Segments Two and Three comparable to women in the second and third trimesters.


Each "type of study in a rat is trying to simulate what would occur in a woman at those different stages," Parisian explained to the jury.


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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
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