The letter is also worth reading as a guide for laypersons to the way statistics can be manipulated in ads:
The journal ad claims that "[ACZONE] Works fast 24% reduction in inflammatory lesions at 2 weeks" (emphasis in original). This claim is a complete misrepresentation of the results of the Draelos study. [J Am Acad Dermatol. 2007.]That bold type was in the original FDA letter. On the manipulation of statistics, the FDA said:
... at 2 weeks, the mean percent change in inflammatory lesion count in patients on dapsone gel was 24% and in patients on placebo was 22%, demonstrating an actual effect of 2%, which was not even nominally statistically significant (p=0.052).Wait for the adverb, also in bold:
... the journal ad grossly overstates the efficacy of the drug by presenting only the most favorable result for ACZONE and ignoring the placebo response ...
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