Question
The cholesterol-lowering drugs Zetia and Vytorin, made by Merck and Schering-Plough, are used by almost a million Americans every week at a cost of around
The cholesterol-lowering drugs Zetia and Vytorin, made by Merck and Schering-Plough, are used by almost a million Americans every week at a cost of around $4 billion per year. Despite tremendous growth in their use, there are no published clinical trials that compared these two drugs to other competing medicines.After completing an important study of the effectiveness of these drugs, but before publishing the data, the companies announced they had decided to change the goal of the study from measuring the drugs' effectiveness in reducing cholesterol to measuring the drugs' effectiveness in reducing harmful plaque formation.
A spokesperson for the companies says that this goal change should not impact the credibility of the study as long as the p-value for the new goal is less than 5% -- the traditional cut-off for statistical significance.Another researcher responds, says that goals for a study should be decided in advance and never changed.Assuming both goals are of similar medical importance, do you agree with the spokesperson or do you agree with the researcher? Explain briefly.
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