"GSK's experts, on the other hand, are anti-lumping," she said. "They say that you can't lump all heart defects together because they form for different reasons at different times by different processes and that you can't use evidence as to one kind of defect to imply that it also applies to another kind of cardiac defect."
"And GSK's experts will tell you that statistical significance matters," she stated, "that without applying the tool of statistical significance, you have no idea whether the difference between the two groups is real and meaningful or whether it is simply the operation of chance or coincidence."
Studies Designed to Fail
During his September 15, 2009 opening statement, the family's lead attorney, Sean Tracey, told the jury: "You are going to hear from experts in this case that there are ways to design studies to fail."
"If you truly don't want to know the truth," he said, "very smart people can design studies that won't show you the truth."
Dr Shira Kramer, an epidemiologist, testified as an expert for the plaintiffs. Kramer was asked to explain what is meant by "inclusive by design." It's "a very, very serious problem that has been written about quite a bit," she told the jury.
The reason for "the tremendous amount of concern and literature on this topic," she said, "is many of these studies look like they have been designed to fail."
It's the "deliberate design of epidemiological studies in such a way as to make it, if not impossible, extraordinarily difficult to detect relationship between an exposure and an outcome or a disease," Kramer explained.
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