by Ben Vernia | April 14th, 2011
On April 13, former InterMune CEO Scott Harkonen was sentenced to three years’ probation including six months of home confinement, following his conviction for mail fraud. Harkonen was convicted in September 2009, at a trial in which a federal jury acquitted him of misbranding under the Food, Drug and Cosmetic Act.
According to DOJ’s press release:
W. Scott Harkonen, M.D., the former chief executive office (CEO) of InterMune Inc., was sentenced Wednesday before U.S. District Court Judge Marilyn Hall Patel for wire fraud relating to the dissemination of false and misleading statements about the results of a clinical trial of InterMune’s drug Actimmune. Judge Patel sentenced Harkonen to three years’ probation, with six months of home confinement. He was ordered to pay a $20,000 fine and to perform 200 hours of community service. In September 2009, after a seven-week trial, a jury convicted Harkonen of wire fraud for the creation and dissemination of false and misleading information about the efficacy of Actimmune (Interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis (IPF).
Evidence at trial showed that Harkonen was the CEO of InterMune from February 1998 through June 30, 2003 and a member of InterMune’s board of directors. Under Harkonen’s direction, InterMune marketed and sold Actimmune to treat the fatal disease IPF despite the fact that Actimmune was not approved by the Food and Drug Administration (FDA) as a safe and effective treatment. The cost of Actimmune for one IPF patient for one year was approximately $50,000 and the vast majority of the sales of Actimmune were for the unapproved, off-label use of treating IPF.
Evidence at trial further showed that Harkonen caused InterMune to issue a false and misleading press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF on Aug. 28, 2002. Although the clinical trial had failed, InterMune’s press release falsely stated that the results of the clinical trial established that Actimmune helped IPF patients live longer. The headline of the press release read, “InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF,” with the subheading “Reduces Mortality by 70% in Patients With Mild to Moderate Disease.”
In October 2006, InterMune agreed to enter into a deferred prosecution agreement and to pay nearly $37 million to resolve criminal charges and civil liability in connection with the illegal promotion and marketing of its drug Actimmune. InterMune also entered into a five-year Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services.
