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General News    H4'ed 3/4/10

Ghostbusting in Paxil Birth Defect Litigation

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Evelyn Pringle
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During re-direct, Tracey asked Healy to tell the jury what the actual results of the study that Nemeroff was discussing in the presentation showed, and specifically when Paxil was looked at alone. The results "showed that there was a 1.8-fold increase in the odds ratio of a birth defects to the women who have been taking Paxil during pregnancy," Healy testified.


"Overall, for this group of drugs there was an increase in risk," he said, "but specifically for Paxil the risk was greatly increased."


"And beyond that," Healy stated, "what isn't included here in the conclusions, overall there was a -- on this group of drugs, there was a doubling of the rate of miscarriages on the drug compared with the rate of miscarriage for the women who are being compared who weren't on the drug."


"There was also an increased rate of women going on to voluntarily abortions on the drug," he added.


One of the lead authors on the study was Gideon Koren. "Doctor, without giving any details," Tracey asked Healy, "do you know whether Doctor Koren has ties to the pharmaceutical industry?"


"I know he has," Healy said.


During his opening statement, Tracey told the jury that 1998 was a big year for Paxil because a study came out by a doctor named Gideon Koren, and a researcher named Kulin, that looked at Paxil and two other SSRIs.


The study compared women who took SSRIs, to women who didn't take any SSRIs, and the number of birth defects in the two groups was the same. "So Doctor Koren concluded that SSRIs appear to be safe," Tracey said.


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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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