Pharma Execs Take Note: Harkonen Convicted of Wire Fraud

A warning to pharma execs who are inclined to bury missed primary endpoints of clinical trials in press releases: You are personally at risk of federal indictment and conviction. No more hiding behind the company shield.

Case in point: Scott Harkonen

The former CEO of InterMune, was found guilty of wire fraud last week in a San Francisco federal court, reported the DoJ in a September 29 statement.* As a result, Harkonen faces up to $250,000 in fines and 20 years in prison. The jury-trial conviction relates primarily to a press release issued by InterMune on August 28, 2002, and reportedly at Harkonen's direction. 

The InterMune press release in question (reprinted here) claimed, in blatant up-front fashion, that the company's drug Actimmune (interferon gamma-1b) improved overall survival in a phase 3 study of patients with mild-moderate idiopathic pulmonary fibrosis (IPF). However, the trial results failed to show a statistical difference in progression-free survival, the trial's primary endpoint, between Actimmune and standard corticosteroid treatment. News of the missed primary endpoint was buried in the first paragraph of InterMune's press release and overshadowed by follow-up praise for the trial results provided by Harkonen and the study's lead investigator, Ganesh Raghu.

In January 2004, Raghu and his scientific colleagues published the results of the same trial in the NEJM. There the peer-reviewed data failed to show that Actimmune significantly improved progression-free survival, pulmonary function, or quality of life. Later that year, the DoJ launched an investigation of InterMune and its promotion of Actimmune for the off-label indication of IPF. The investigation culminated in InterMune paying a $37-million settlement to the government in October of 2006 (for a detailed timeline of InterMune's troubles, go here).** Harkonen was separately indicted by the DoJ in March of last year.

Harkonen resigned from InterMune in June 2003 and is currently President and CEO of Comentis, a San Francisco-based biotech. Notably, in his legal defense, Harkonen claimed that the InterMune press release should be protected by the free-speech clause of the First Amendment. Harkonen argued that he was engaging in "scientific debate"; the judge, however, failed to buy the argument, possibly because she found the press-release statements to be misleading.

* Harkonen was simultaneously acquitted of a misbranding charge.

** In 2007, the clinical investigation of Actimmune in IPF was abandoned by InterMune after interim results of another phase 3 trial showed no survival benefit with drug. InterMune is currently investigating pirfenidone in IPF.