Actimmune was approved for severe, malignant osteopetrosis in children. The feds alleged InterMune promoted it off-label for idiopathic pulmonary fibrosis in adults.
A jury acquitted Harkonen of off-label promotion of Actimmune, but convicted him of wire fraud based on the press release. Not helping Harkonen's case was the fact that he ordered Actimmune T shirts for his staff that said "Feel Better Live Longer" on them, to celebrate a clinical trial that had not shown any benefit for patients suffering from IPF.
An early study of Actimmune in IPF patients showed no overall benefit for patients. But a retrospective subgroup analysis showed benefits in mild-to-moderate sufferers. Harkonen wrote a press release about the results, the indictment said:
Harkonen wrote the headline and byline and controlled the entire content of the press release. The press release contained false and misleading information regarding Actimmune and falsely portrayed the results of the GIPF-001 Phase III trial as establishing that Actimmune helped IPF patients live longer.The headline said:
InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF; Reduces Mortality by 70% in Patients With Mild to Moderate Disease.A later, full trial in mild-to-moderate IPF patients ultimately found no benefit.