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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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One thing is undisputed in this case, Tracey said. "They never did the test at the higher level with the rabbit to figure out whether or not this drug was a teratogen."


"If what a drug company really wants to know is whether or not their drug is dangerous, they test it. They don't avoid tests," he told the jury in closing arguments.


"Because the negative result will cost us money is not a defense to not finding out the truth about your drug," he pointed out.


Secret Reports


During her testimony, Parisian explained that once a drug is approved it is the manufacturer's job to do pharmacovigilance.


The clinical trials done to get a new drug approved typically do not have women that are pregnant, she testified. Once a drug is marketed, the company will start getting data about mothers who are pregnant and their babies and it's "the duty of the manufacturer to monitor that," she said.


In the case of Paxil, the trials excluded both women who were pregnant and women who could become pregnant because the animal date suggested that there was a risk, she noted, citing a 1984 FDA letter.


While testifying, Peavy had Parisian review a 1997 internal Glaxo document titled, "Paroxetine: Pregnancy with Abnormal Outcomes," discussing the reporting of birth defects in Japan.


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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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