Sunday, March 23, 2008

FDA Rejects the Ancient Art of Kanly (and Off-Label Drug Marketing)

I CAN'T BE THE ONLY science fiction reader who did a double-take upon reading this item, by Elizabeth Olson, from the New York Times website's Suits personality-graball column:
The former chief of a small California biotechnology company had criminal charges brought against him last week for his suspected role in promoting a drug that prosecutors said was not approved to treat a fatal lung disease.

The company’s former executive, W. Scott Harkonen, a medical doctor who headed Intermune until June 2003, was indicted on wire fraud and other charges over the marketing and selling of the drug Actimmune, which was approved by the Food and Drug Administration only to treat two rare childhood diseases.

Prosecutors said Intermune, based in Brisbane, Calif., was illegally marketing the drug to treat idiopathic pulmonary fibrosis. The drug had $141 million in sales in 2003. Three years later, it agreed to pay $36.9 million to settle federal claims that it sold Actimmune for unapproved uses.

The company noted in a statement that “the government is bringing charges against a former employee” — not against the company or its current employees or directors.

Mr. Harkonen, 56, is now chief executive of CoMentis, a research firm in South San Francisco, Calif., developing drugs to combat Alzheimer’s disease.

His lawyer, James J. Brosnahan, issued a statement saying that “Dr. Harkonen is innocent of the charges brought against him.”
No word on whether the Doc will have to surrender his considerable spice holdings on Arrakis, but that's for the rest of the Landsraad to decide.

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