Article: Paxil Birth Defect Litigation - First Trial A Bust For Glaxo

During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.

A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony.

Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.

When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company "do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born," she said.

"Cross-fostering is ... taking rats from treated mothers and putting them with a control rat that didn't receive the drug," she explained to the jury. "So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born."

The FDA asked Glaxo to submit a protocol for the study, "for our concurrence," before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.

She testified that such a study "would have helped to address where the negative effects were coming from."

While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam's mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.

The label stated: "in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester."

Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label "implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester," she testified.

The label is saying "there is no evidence of teratogenic effects," she said, "that means that it's safe for the first trimester. "

"If a physician were to read this, they would be more likely to prescribe it early in pregnancy," she told the jury.

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