It was the best research Emily’s doctor had never heard about.*
Emily was a delightful 6-year-old with molluscum contagiosum (MC). Characteristic dome-shaped umbilicated papules, some of them itchy, peppered her chest and buttocks. Emily had returned to the clinic, where one of us (KAK) saw her, after she failed treatment with imiquimod 5% cream.
Coincidentally, Emily was born just as 2 rigorously conducted randomized controlled trials (RCTs) of imiquimod for treatment of MC in children were concluding. In both studies, imiquimod proved ineffective. Six years later, and 5 years after imiquimod’s package insert (PI) had been updated to include those RCT results, no studies had shown otherwise.
So why was Emily prescribed imiquimod? It would be easy to blame Emily’s doctor.
But it’s not that simple.
The real problem lies in a federal law that allows data from pediatric drug studies requested by the federal government and subsidized by...