Healthy Skepticism Library item: 13219
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Bartz D.
Former InterMune CEO indicted for promoting drug
Reuters 2008 Mar 18
http://www.reuters.com/article/marketsNews/idUKN1824386120080318?rpc=44
Full text:
InterMune Inc’s former chief executive was indicted on Tuesday for falsely promoting the company’s drug Actimmune as a treatment for a fatal lung disease, the Justice Department said on Tuesday.
Federal prosecutors alleged that under former CEO Scott Harkonen’s direction, InterMune put out a press release in 2002 saying a clinical trial showed that Actimmune was effective in treating idiopathic pulmonary fibrosis (IPF), a scarring of the lung tissue.
But the clinical trial, the indictment said, in fact showed Actimmune was ineffective in treating IPF.
The Food and Drug Administration has only approved Actimmune for severe osteoporosis and chronic granulomatous disease, a disorder of immune cells that kill bacteria.
Harkonen’s lawyer said his client was innocent of the charges against him.
“The New England Journal of Medicine published a twelve-month study stating that Actimmune was associated with substantial improvements in the condition of IPF patients,” said lawyer James Brosnahan. “There were additional extensive clinical studies and at all times (Food and Drug Administration) approval was diligently pursued.”
In October 2006, InterMune agreed to pay nearly $37 million to resolve criminal and civil charges in connection with the case.
Harkonen is charged with wire fraud and fraud in connection with medical drug sales. If convicted on all charges, he could be sentenced to 23 years in prison.
“The vast majority of InterMune’s sales of Actimmune were for the unapproved, off-label use of treating IPF,” the indictment said. “The cost of Actimmune for one IPF patient for one year was approximately $50,000.”
