"This information about GSK's involvement and manipulation of the Louik study is something that has recently come to light," Tracey said. "In fact, the deposition of their epidemiologist, Sara Ephross, was taken after ... the deadline for Doctor Kramer's report."
"And, in fact, last week, while we were in trial," he told the judge, "a Federal Court in Boston has ordered the Slone Epidemiology Center and GSK to turn over documents related to their involvement in this study."
"Quite frankly," he said, "the only people prejudiced by this are the plaintiffs, because GSK knows exactly what they did and when they did it, and we have been trying to get this information for some time."
The judge excluded testimony about an email exchange between Dr Loiuk and Ephross.
But the comments by Louik, not seen by the jury, that appeared in court filings, stated in part: "we did not accept your changes. We are trying to avoid reinforcing the widely held perception that "statistical significance' is a standard by which to judge the validity of a study finding. Significance is a function of study size, and while a single non-significant result might not be credible, in this case it supports findings from other studies and should not be dismissed for reasons of significance alone."
In the affidavit filed in the Federal Court that ordered the release of the communications between Glaxo and the Slone Center, Louik wrote: "We rejected all of GSK's suggestions that might have served to weaken our findings and conclusions."
"GSK suggested that our "overall' findings did not support the hypothesis that Paxil increases the risk of cardiac defects," she stated. "We rejected that suggestion as well."
Birth Defect Numbers Halt
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