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Ex InterMune CEO Indicted for Actimmune Promotion

Mar 19, 2008 | Parker Waichman LLP InterMune Inc.'s former chief executive officer, Scott Harkonen, was indicted on Tuesday for falsely promoting the company's drug Actimmune as a treatment for the fatal lung disease idiopathic pulmonary fibrosis (IPF) the Justice Department said on Tuesday.

Acctimmune is a genetically engineered form of the protein interferon gamma which stimulates the human immune system.  Actimmune was approved by the US Food and Drug Administration (FDA) only for use in children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis.

CGD is comprised of a group of inherited immune system disorders caused by defects in immune cells called phagocytes.  These cells recognize and destroy microbial pathogens.  In patients with CGD, phagocytes do not generate sufficient levels of the enzymes responsible for killing ingested microorganisms, leaving patients vulnerable to severe, recurrent bacterial and fungal infections and chronic inflammatory conditions like gingivitis, enlarged lymph glands, and tumor-like masses called granulomas. While not malignant, granulomas can cause serious problems by reducing airflow in the lungs, obstructing the passage of food through the gastrointestinal system, and preventing the flow of urine through the kidneys and bladder.  Granulomas are a major recurring feature chronic granulomatous disease.  In severe, malignant osteopetrosis—a rare life-threatening congenital disorder—the patient develops abnormally dense and brittle bone structures, which compromises bone marrow space and impairs cranial nerve function.  
As a result, patients have an increased risk of anemia, blindness, hearing loss, and infection.  Actimmune acts to prevent infection in these patients.

Federal prosecutors alleged that under former CEO Scott Harkonen's direction, InterMune put out a press release in 2002 stating that a clinical trial showed that Actimmune was effective in the treatment of IPF.  IPF is a life-threatening scarring of the lung tissue in which the air sacs of the lungs become replaced by fibrotic tissue.  When the scar forms, the tissue becomes thicker, causing an irreversible loss of the tissue’s ability to transfer oxygen into the bloodstream.  There are currently neither any effective treatments nor a cure for Idiopathic Pulmonary Fibrosis.

The indictment states that in the clinical trial, Actimmune was ineffective in treating IPF.  "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."  Off-label uses are permissible with physician discretion; however, drug makers are prohibited by law from marketing drugs for off-label uses.

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."

Harkonen is charged with wire fraud and fraud in connection with medical drug sales. If he is convicted on all charges, Harkonen could be sentenced to 23 years in prison.  In October 2006, InterMune agreed to pay nearly $37 million to resolve criminal and civil charges in connection with the case.

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