"And since no such study was ever done," she told the jury, "you would not expect to find any specific study that would have been able to analyze interrupted aortic arch Type A as a specific subgroup."
Most of the studies, she said, "just reported on all cardiac malformations as a group and even those that ... did any kind of subgroup analysis restricted them to the most common subgroups."
There were several studies where they restricted any analysis to subgroups where they had at least 200 women whose child suffered a specific birth defect, "which would automatically exclude IAA Type A," she explained.
The Louik paper restricted the analysis to subgroups of 100, she said. But the "Louik study itself very clearly lists IAA as a specific cardiac malformation under conotruncal defects in their appendix where they list specific subgroups that they looked at and considered," Kramer told the jury.
Louik Study
The Louik study was funded by Glaxo and conducted out of the Slone Epidemiology Center For Birth Defects. While Kramer was testifying earlier, Tracey put up a slide entitled, "Louik, et al - GSK involvement," and told her to tell "the jury what GSK's involvement in this study was both publicly and then privately."
Davis objected to this testimony. "There is nothing in Doctor Kramer's expert report that discusses anything about communications with GSK that somehow impacted the Louik study, so there has been no notice to GSK that she would be offering those opinions today," he argued to the judge, while the jury was out of the courtroom.
"Your Honor," Tracey told the judge, "this issue is something that has been percolating for a number of years."
"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
