FDA Gives Allergan a Stats Lesson in Bold Type

Could the FDA be signalling a more aggressive regulatory stance under the Obama administration through its use of dramatic adverbs and bold type? That’s one way to read a warning letter the FDA sent to Allergan regarding a journal ad for its Aczone acne product.

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 …

Got that?

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