Fraud charges were filed this week against the former CEO of Brisbane-based InterMune, reported AP writer Paul Elias for SF Gate. 

Elias reported as follows:

Dr. W. Scott Harkonen served as the Brisbane-based company’s top executive from 1998 until 2003. During that time, he is accused of making false and misleading statements about how effective the drug was in combatting the fatal lung disease idiopathic pulmonary fibrosis, known as IPF.

A press release Harkonen wrote touting the benefits of Actimmune to treat the lung disease in August 2002 is at the heart of the government’s case. The press release stated that a large-scale scientific test of Actimmune showed it helped IPF patients live longer, prompting many doctors to start prescribing the drug for IPF even though it wasn’t approved for that disease. . . . Doctors are allowed to write so-called "off-label" prescriptions for drugs, but companies are prohibited from directly marketing those uses. Prosecutors allege that the test Harkonen cited in the press release was a failure and that there’s no proof the drug played any role in extending life. .. ."

According to Elias, Dr. Harkonen, who is now the CEO of CoMentis, Inc. in South San Francisco, intends to plead not guilty. 

According to the Wall Street Journal Health Blog, the government does on occasion come down on a company for off-label marketing, sometimes even naming individuals; however, it is unusual for the investigation to focus on a single executive and file criminal charges against him rather than the company.  In this case, Harkonen is being indicted on charges of wire fraud and for violations of the Food, Drug and Cosmetic Act.