subgroup analysis can lead to jail

8 Nov

Image via Wikipedia

A scientist that undertook a subgroup analysis passed nearby a prison sentence in the US.

W. Scott Harkonen have been convinced of false dissemination and misleading statement for his interpretation by subgroup analysis of  a clinical trial results.  He is accused by the Feds of manipulating the data with a subgroup analysis such modifying the primary endpoint of the trial. The following dissemination of the results he obtained provoked a wide off label prescription of the drug tested in the trial. The consequences were inappropriate spending for Medicaid and Medicare. The cost of off label prescription for one patient-year was approximately $50,000. This cost is proportional to the severity of the sentence pronounced by the judge. Pharmalot reported this lawsuit in several posts, the last report being available here.


One Response to “subgroup analysis can lead to jail”


  1. Subgroup analyses « Health Services Authors - December 11, 2011

    […] subgroup analysis can lead to jail ( […]

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