"This whole issue of rejection of a hypothesis, yes-no answers," she explained, "was created for agricultural and industrial studies, whether or not a certain widget would be produced more efficiently in one production method than another or whether one field is more productive than another in an agricultural setting, these are easy yes-no answers and don't impact human health."
A single-minded focus on significance testing is dangerous from a public health perspective, she said, because "it leads to discarding very important and relevant data and studies."
Glaxo's Own Meta-Analysis
While testifying, Kramer explained that a "meta-analysis is an analysis of all the data that have been generated on a subject, so it's an agglomeration, a statistical analysis of all the data to come up with a summary risk for all of the studies together."
"It's an attempt to overcome the issue of small sample sizes," she said, "so the individual doing the meta-analysis will take all of the studies and will actually combine all of the results into summary statistics so that there is more power and there is some attempt to come up with a summary of all of the data that have been generated to date."
The famous neuropsychopharmacology expert from Wales, Dr David Healy, also testified for the plaintiffs. During his testimony, the jury was presented with two charts from Glaxo's own website, showing the results of its own internal meta-analysis of the existing epidemiological studies.
The analysis had only been put on the website recently, he noted, maybe last year. One chart showed all birth defects lumped together, or combined, and the other showed cardiac birth defects.
In discussing the chart on combined birth defects, Healy said, "what everybody here needs to see is ... the little dots in the middle of the lines."
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