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« Reply #3 on: September 08, 2010, 06:31:32 AM »

Almost like an episode of the TV show, Cold Case Files, the first Paxil birth defect trial was dominated by a story about what happened to the rat pups that died around 1979 and1980, involved in a study in which Paxil was being tested on pregnant female rats.
The animal studies giving Paxil to rats and rabbits were conducted by a Danish company called Ferrosan before the drug maker, that later became part of GlaxoSmithKline, purchased the drug.
The family's lead attorney in the case of Kilker v Glaxo, Sean Tracey from Houston, brought in the world-famous neuropsychopharmocology expert from Wales, Dr David Healy, to testify extensively about rat pup study 295.
In summary, Healy told the jury that all the rat pups born to mothers who received Paxil were dead four days after they were born, while eighty-eight percent of the pups not exposed to Paxil were still alive on day four.
In fact, of the 415 rat pups born to mothers who received Paxil, Healy testified that, "One in every ten or actually maybe more like possibly one in every eight or so were born dead."
As far as he could make make out, all the rats were not autopsied, Healy said, so the question was why the pups died.
"It's clearly the drug that has caused the death," he told the jury.
"One of the possible reasons for their death is they're born with birth defects that lead to them actually dying early in infant life," he testified. "A responsible approach to data like this is to investigate it further and find out just what the cause is."
Doctor Suzanne Parisian, a former FDA scientist, also served as an expert for the plaintiffs. She testified that the first safety signals that indicated Paxil could cause birth defects were seen in the animal studies conducted in 1979-1981 period, as well.
Parisian said the studies showed birth defects, embryos that died, and rat pups that did not survive.
Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony. While testifying, Peavy had Parisian review comments in a memo by a Doctor John Baldwin to Glaxo in 1980, discussing the Ferrosan studies, which stated: "There remains the possibility that this compound could be teratogenic at high-dose levels."
"We need to ascertain whether Ferrosan have conducted or are conducting or intend to conduct a peri- and postnatal study and a neonatal acute toxicity study," Baldwin wrote.
Based on her review the documents, Parisian told the jury, Glaxo never ascertained whether Ferrosan did the studies and Glaxo never conducted the studies.
As far as she knew, the company never told the FDA about Baldwin's statements either, she said, but "they should have."
On October 13, 2009, the jury in Philadelphia rendered a verdict against Glaxo and awarded the family $2.5 million. More than 600 Paxil birth defect cases are pending in the multi-litigation in Pennsylvania.
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In May 2009, a paper was published by a Doctor Sloot and the complete version of the study came out in September 2009. During closing arguments, Tracey told the jury, the "Sloot study is probably the single most problematic document in this case for them because it could have easily been done."
"They would have known that the drug was a clear teratogen. It was more powerful than cocaine," he said. "And it was more powerful a teratogen than even the control or as powerful as the control retinol that everybody in this courtroom, everybody that has testified, has said that drug is a teratogen."
"And had GSK done the studies that Baldwin told them they should do, or a study like Sloot, any time before they started marketing," he told the jury, "we wouldn't be here."
Retinol is an active ingredient in Accutane, a pregnancy Category X drug, meaning it is known to cause birth defects and is not to be used by pregnant women.

During his testimony, Healy was asked to tell the jury what the Sloot study was seeking to do.

"Schering-Plough had acquired a different European company called Organon who had a number of drugs which were serotonin reuptake inhibiting drugs," he explained.

"One of the things that Schering-Plough wished to find out was could they bring any of these drugs to the market," he said.

"What they then did was to do reproductive toxicology studies on these drugs that were new to them, plus on, I believe, all of the SSRI drugs that were on the market, plus a number of drugs which also inhibit serotonin reuptake, like cocaine, and they threw into the mix one or two more drugs, one that was known not to cause birth defects and one that was known to cause birth defects closely related to Accutane," he told the jury.

They had a "particular system to look at the impact of all these drugs on the developing fetus to see were there any indicators of risk," he said, using rat fetuses.

The study "found that Paxil, of all the SSRIs on the market now, was the most likely to cause birth defects and caused birth defects at the same rate as Accutane did," Healy said.

He was asked how Paxil did in the study compared to cocaine in terms of potency.


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« Reply #5 on: September 08, 2010, 04:34:11 PM »

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Although Paxil was not approved in Japan until 2000, a couple years after it was approved in the US in 1992, Glaxo began looking into marketing the drug in Japan and meeting the requirements for approval by the Minister of Health and Welfare (MHW), the Japanese equivalent to the FDA.

"And the Japanese, they suspected, were not going to accept their dead rat pup studies," Tracey told the jury in his opening statement on September 15, 2009.

"And so GSK began discussions internally," he said. "Internally among themselves they said: What are we ... going to do if Japan makes us do the studies to find out why the rat pups died?"

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